RECRUITING

Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

Official Title

A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Quick Facts

Study Start:2021-11-12

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04628767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* STEP 1 REGISTRATION AND RANDOMIZATION * Patients must be \>= 18 years of age * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 12 weeks (84 days) prior to registration/randomization with one of the following: * Upper urinary tract mass on cross-sectional imaging or * Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology * NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice * Leukocytes \>= 3,000/mcL (obtained =\< 14 days prior to registration/randomization) * Platelets \>= 100,000/mcL (obtained =\< 14 days prior to registration/randomization) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (or =\< 2.5 x ULN for patients with Gilbert's disease) (obtained =\< 14 days prior to registration/randomization) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained =\< 14 days prior to registration/randomization) * Hemoglobin (Hgb) \>= 9 g/dL (obtained =\< 14 days prior to registration/randomization) * NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration/randomization are eligible for this trial * NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \< 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months * NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count \< 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count \>= 250 cells/mcL within 7 days of registration/randomization * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Patient must have a body weight of \> 30 kg * Patient must have life expectancy of \>= 12 weeks * Patient must have creatinine clearance \> 15 ml/min as by Crockroft-Gault formula or 24-hour creatinine clearance within 28 days prior to registration/randomization * NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and/or hearing loss in keeping with SOC cisplatin contraindications. Patients that are cisplatin-eligible will be randomized to either Arm A or Arm B * Patients that meet any of the following criteria will be registered and assigned to the cisplatin-ineligible Arm C if they meet other eligibility criteria: * Creatinine clearance \> 15 ml/min and =\< 50 ml/min or hearing loss grade \>= 3, or neuropathy \>= 2, or ECOG PS 2 * Patient must have an absolute neutrophil count (ANC) \>= 1,000/mcL obtained =\< 14 days prior to registration * Patient must have ECOG performance status 0-2 * Patients that meet the following criteria will be randomized to the cisplatin-eligible Arm A or Arm B: * Patient must have creatinine clearance of \> 50ml/min, PS ECOG 0-1, absence of hearing loss grade \>= 3, and/or neuropathy \>= 2 * Patient must have an absolute neutrophil count (ANC) \>= 1,500/mcL obtained =\< 14 days prior to randomization * Patient must have left ventricular ejection fraction (LVEF) \>= 50% by (either multigated acquisition scan \[MUGA\] or 2-D echocardiogram) obtained within obtained within 28 days prior to randomization	* Patients must not have any component of small cell/neuroendocrine carcinoma. Other variant histologic types are permitted provided the predominant (\>= 50%) subtype is urothelial carcinoma * Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patients of childbearing potential and sexually active patients must not expect to conceive or father children, either by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment * Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (\>= 1.5 cm short axis) on imaging required within 28 days prior to registration (Non-regional findings \>=1.5 cm short axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on positron emission tomography (PET) or other imaging or other criteria can be eligible based on investigator discretion). * NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scans to evaluate for bone metastasis at the discretion of local provider. * Patient must meet below criteria for prior/current malignancy history: * Non-urothelial cancer malignancy history: * Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =\< Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat * NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients in whom concomitant or prior bladder/urethra predominant (\>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (\< cT1N0) are eligible regardless of time elapsed * Urothelial cancer malignancy history: * Patient may have a history of resectable urothelial cancer as long as patients meet one of the following: * T0, Ta or Tis at any time * T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy \[e.g., radical surgery, transurethral resection of bladder tumor (TURBT), radiation, chemotherapy (neoadjuvant or adjuvant, or with radiation)\]. Prior immune checkpoint inhibitor is not allowed. * Patient with history of \>= pT4b, N+, and/or M1 is not eligible. * NOTE: Patients in whom concomitant or prior bladder/urethra predominant (\>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or carcinoma in situ (CIS) (\< cT1 N0) are eligible regardless of time elapsed * Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis \[TB\] testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) in last three months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, clinically relevant liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements * Patient must not have received prior radiation therapy to \>= 25% of the bone marrow for other diseases * Patient must not have received prior systemic anthracycline therapy * NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible * Patient must not have either history of or active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration/randomization or any history of inflammatory bowel disease (inflammatory bowel disease \[IBD\], colitis, or Crohn's disease), neuromuscular autoimmune condition, immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition are eligible * Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion: * Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment * Steroids as premedications for hypersensitivity reactions (e.g. computed tomography \[CT\] scan premedication) * Patient must not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab, while on protocol treatment and within 30 days after the last dose of durvalumab * Patient must not have had a major surgical procedure within 28 days prior to registration/randomization * NOTE: Cystoscopy/ureteroscopy, stent placement or nephrostomy tube is not considered major surgery * Patient must not have history of allogenic organ transplantation

Inclusion Criteria

Exclusion Criteria

* STEP 1 REGISTRATION AND RANDOMIZATION
* Patients must be \>= 18 years of age
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 12 weeks (84 days) prior to registration/randomization with one of the following:
* Upper urinary tract mass on cross-sectional imaging or
* Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology
* NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice
* Leukocytes \>= 3,000/mcL (obtained =\< 14 days prior to registration/randomization)
* Platelets \>= 100,000/mcL (obtained =\< 14 days prior to registration/randomization)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (or =\< 2.5 x ULN for patients with Gilbert's disease) (obtained =\< 14 days prior to registration/randomization)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained =\< 14 days prior to registration/randomization)
* Hemoglobin (Hgb) \>= 9 g/dL (obtained =\< 14 days prior to registration/randomization)
* NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration/randomization are eligible for this trial
* NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \< 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months
* NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count \< 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count \>= 250 cells/mcL within 7 days of registration/randomization
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Patient must have a body weight of \> 30 kg
* Patient must have life expectancy of \>= 12 weeks
* Patient must have creatinine clearance \> 15 ml/min as by Crockroft-Gault formula or 24-hour creatinine clearance within 28 days prior to registration/randomization
* NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and/or hearing loss in keeping with SOC cisplatin contraindications. Patients that are cisplatin-eligible will be randomized to either Arm A or Arm B
* Patients that meet any of the following criteria will be registered and assigned to the cisplatin-ineligible Arm C if they meet other eligibility criteria:
* Creatinine clearance \> 15 ml/min and =\< 50 ml/min or hearing loss grade \>= 3, or neuropathy \>= 2, or ECOG PS 2
* Patient must have an absolute neutrophil count (ANC) \>= 1,000/mcL obtained =\< 14 days prior to registration
* Patient must have ECOG performance status 0-2
* Patients that meet the following criteria will be randomized to the cisplatin-eligible Arm A or Arm B:
* Patient must have creatinine clearance of \> 50ml/min, PS ECOG 0-1, absence of hearing loss grade \>= 3, and/or neuropathy \>= 2
* Patient must have an absolute neutrophil count (ANC) \>= 1,500/mcL obtained =\< 14 days prior to randomization
* Patient must have left ventricular ejection fraction (LVEF) \>= 50% by (either multigated acquisition scan \[MUGA\] or 2-D echocardiogram) obtained within obtained within 28 days prior to randomization

* Patients must not have any component of small cell/neuroendocrine carcinoma. Other variant histologic types are permitted provided the predominant (\>= 50%) subtype is urothelial carcinoma
* Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patients of childbearing potential and sexually active patients must not expect to conceive or father children, either by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment
* Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (\>= 1.5 cm short axis) on imaging required within 28 days prior to registration (Non-regional findings \>=1.5 cm short axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on positron emission tomography (PET) or other imaging or other criteria can be eligible based on investigator discretion).
* NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scans to evaluate for bone metastasis at the discretion of local provider.
* Patient must meet below criteria for prior/current malignancy history:
* Non-urothelial cancer malignancy history:
* Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =\< Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat
* NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients in whom concomitant or prior bladder/urethra predominant (\>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (\< cT1N0) are eligible regardless of time elapsed
* Urothelial cancer malignancy history:
* Patient may have a history of resectable urothelial cancer as long as patients meet one of the following:
* T0, Ta or Tis at any time
* T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy \[e.g., radical surgery, transurethral resection of bladder tumor (TURBT), radiation, chemotherapy (neoadjuvant or adjuvant, or with radiation)\]. Prior immune checkpoint inhibitor is not allowed.
* Patient with history of \>= pT4b, N+, and/or M1 is not eligible.
* NOTE: Patients in whom concomitant or prior bladder/urethra predominant (\>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or carcinoma in situ (CIS) (\< cT1 N0) are eligible regardless of time elapsed
* Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis \[TB\] testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) in last three months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, clinically relevant liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements
* Patient must not have received prior radiation therapy to \>= 25% of the bone marrow for other diseases
* Patient must not have received prior systemic anthracycline therapy
* NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible
* Patient must not have either history of or active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration/randomization or any history of inflammatory bowel disease (inflammatory bowel disease \[IBD\], colitis, or Crohn's disease), neuromuscular autoimmune condition, immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition are eligible
* Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion:
* Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment
* Steroids as premedications for hypersensitivity reactions (e.g. computed tomography \[CT\] scan premedication)
* Patient must not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab, while on protocol treatment and within 30 days after the last dose of durvalumab
* Patient must not have had a major surgical procedure within 28 days prior to registration/randomization
* NOTE: Cystoscopy/ureteroscopy, stent placement or nephrostomy tube is not considered major surgery
* Patient must not have history of allogenic organ transplantation

Contacts and Locations

Principal Investigator

Jean H Hoffman-Censits

PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

Kingman Regional Medical Center

Kingman, Arizona, 86401

United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Sutter Auburn Faith Hospital

Auburn, California, 95602

United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

Palo Alto Medical Foundation-Fremont

Fremont, California, 94538

United States

Memorial Medical Center

Modesto, California, 95355

United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, 94040

United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

United States

Sutter Roseville Medical Center

Roseville, California, 95661

United States

Sutter Medical Center Sacramento

Sacramento, California, 95816

United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115

United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, 95065

United States

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403

United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086

United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589

United States

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045

United States

Poudre Valley Hospital

Fort Collins, Colorado, 80524

United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528

United States

UCHealth Greeley Hospital

Greeley, Colorado, 80631

United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129

United States

Medical Center of the Rockies

Loveland, Colorado, 80538

United States

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

Sibley Memorial Hospital

Washington, District of Columbia, 20016

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

OSF Saint Anthony's Health Center

Alton, Illinois, 62002

United States

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Loyola Center for Health at Burr Ridge

Burr Ridge, Illinois, 60527

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902

United States

SIH Cancer Institute

Carterville, Illinois, 62918

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657

United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Advocate Sherman Hospital

Elgin, Illinois, 60123

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401

United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429

United States

Loyola Medicine Homer Glen

Homer Glen, Illinois, 60491

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

AMG Libertyville - Oncology

Libertyville, Illinois, 60048

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, Illinois, 60160

United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Valley Radiation Oncology

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Reid Health

Richmond, Indiana, 47374

United States

Mary Greeley Medical Center

Ames, Iowa, 50010

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, 52722

United States

McFarland Clinic - Boone

Boone, Iowa, 50036

United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

United States

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129

United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158

United States

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846

United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809

United States

Mary Bird Perkins Cancer Center - Metairie

Metairie, Louisiana, 70002

United States

East Jefferson General Hospital

Metairie, Louisiana, 70006

United States

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006

United States

University Medical Center New Orleans

New Orleans, Louisiana, 70112

United States

Harold Alfond Center for Cancer Care

Augusta, Maine, 04330

United States

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

Biddeford, Maine, 04005

United States

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

Sanford, Maine, 04073

United States

Maine Medical Partners - South Portland

South Portland, Maine, 04106

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346

United States

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346

United States

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan, 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hope Cancer Clinic

Livonia, Michigan, 48154

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044

United States

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341

United States

Newland Medical Associates-Pontiac

Pontiac, Michigan, 48341

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601

United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604

United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764

United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661

United States

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Fairview Ridges Hospital

Burnsville, Minnesota, 55337

United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

United States

Cambridge Medical Center

Cambridge, Minnesota, 55008

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Unity Hospital

Fridley, Minnesota, 55432

United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369

United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Hennepin County Medical Center

Minneapolis, Minnesota, 55415

United States

Health Partners Inc

Minneapolis, Minnesota, 55454

United States

Monticello Cancer Center

Monticello, Minnesota, 55362

United States

New Ulm Medical Center

New Ulm, Minnesota, 56073

United States

Fairview Northland Medical Center

Princeton, Minnesota, 55371

United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379

United States

Lakeview Hospital

Stillwater, Minnesota, 55082

United States

Ridgeview Medical Center

Waconia, Minnesota, 55387

United States

Rice Memorial Hospital

Willmar, Minnesota, 56201

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125

United States

Fairview Lakes Medical Center

Wyoming, Minnesota, 55092

United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, 63011

United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Southeast Cancer Center

Cape Girardeau, Missouri, 63703

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109

United States

Freeman Health System

Joplin, Missouri, 64804

United States

Mercy Hospital Joplin

Joplin, Missouri, 64804

United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401

United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401

United States

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506

United States

Saint Louis Cancer and Breast Institute-South City

Saint Louis, Missouri, 63109

United States

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

CoxHealth South Hospital

Springfield, Missouri, 65807

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Mercy Hospital Washington

Washington, Missouri, 63090

United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052

United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102

United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Saint Barnabas Medical Center

Livingston, New Jersey, 07039

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328

United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534

United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Armes Family Cancer Center

Findlay, Ohio, 45840

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005

United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

United States

Greater Dayton Cancer Center

Kettering, Ohio, 45409

United States

Kettering Medical Center

Kettering, Ohio, 45429

United States

Springfield Regional Cancer Center

Springfield, Ohio, 45504

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601

United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850

United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146

United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243

United States

UPMC Cancer Center-Washington

Washington, Pennsylvania, 15301

United States

Reading Hospital

West Reading, Pennsylvania, 19611

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Parkland Memorial Hospital

Dallas, Texas, 75235

United States

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104

United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080

United States

FHCC South Lake Union

Seattle, Washington, 98109

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

University of Washington Medical Center - Montlake

Seattle, Washington, 98195

United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911

United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022

United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311

United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142

United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Aurora Medical Center in Summit

Summit, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241

United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

ThedaCare Cancer Care - Waupaca

Waupaca, Wisconsin, 54981

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Jean H Hoffman-Censits, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-12

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2021-11-12

Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

Renal Pelvis and Ureter Urothelial Carcinoma