RECRUITING

Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

Conditions

Advanced Esophageal Adenocarcinoma Advanced Gastric Adenocarcinoma Advanced Gastroesophageal Junction Adenocarcinoma Clinical Stage II Esophageal Adenocarcinoma AJCC v8 Clinical Stage III Esophageal Adenocarcinoma AJCC v8 Clinical Stage III Gastric Cancer AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 Clinical Stage IV Gastric Cancer AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Metastatic Esophageal Adenocarcinoma Metastatic Gastric Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Unresectable Esophageal Adenocarcinoma Unresectable Gastric Adenocarcinoma Unresectable Gastroesophageal Junction Adenocarcinoma

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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 addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.

Official Title

Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab Versus Paclitaxel + Ramucirumab in Patients With PD-L1 CPS >/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)

Quick Facts

Study Start:2024-06-24

Study Completion:2027-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06203600

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
* Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma * Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen * Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma * Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 28 days prior to registration for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form * Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy. All treatment for brain metastases must have been completed at least 28 days prior to registration * Participants must have disease progression or intolerance to frontline standard of care (SOC) chemotherapy plus either nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor. Peri-operative chemotherapy plus nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor will count as one line if disease progression occurs while on the therapy or within 6 months of completing the chemotherapy plus nivolumab or pembrolizumab or other PD-1/PD-L1 inhibitor cycle * Participants must not have received more than one prior line of systemic therapy * Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of ≥ 7 days prior to registration * Participants must not have prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agent including events like pneumonitis, myocarditis, renal failure, Guillain barre syndrome, or myasthenia gravis. Participants with endocrinopathy events leading or not to replacement steroids, thyroid hormone, insulin, or cortisol are eligible * Participants must not have received a live attenuated vaccination within 28 days prior to registration * Participants must not have had a major surgery within 28 days or subcutaneous venous access device placement within 7 days prior registration * Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator. Any participants with postoperative bleeding complications or wound complications from a surgical procedure performed in the last eight weeks should be excluded * Participants must not have plans to undergo elective or planned major surgery during the clinical trial * Participants must not have active bleeding or prior history of gastrointestinal (GI) perforation, fistula or significant GI bleeding (requiring transfusion, endoscopic or surgical intervention) within 84 days prior to registration * Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, investigational agents, biologic or hormonal therapy for cancer treatment while receiving treatment on this study * Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy * Participants must not have a history of grade 3 or 4 immunotherapy related toxicities with the exception of hormonal abnormalities like thyroiditis or thyroid derangements * Participants must be ≥ 18 years old * Participants must have Zubrod Performance Status of 0-2 * Participants must have a complete medical history and physical exam within 28 days prior to registration * Leukocytes ≥ 2 x 10\^3/uL (within 28 days prior to registration) * Absolute neutrophil count ≥ 1.2 x 10\^3/uL (within 28 days prior to registration) * Hemoglobin ≥ 9.0 g/dL (within 28 days prior to registration) * Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) (unless liver metastases are present, in which case they must be ≤ 5 x ULN) * Participants must have a creatinine ≤ 1.5 x the institutional ULN OR calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration * Participants' urinary protein must be ≤ 1+ on dipstick or routine urinalysis (UA) within 28 days of registration. Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+, then a 24-hour urine is to be collected and demonstrate \< 1000 mg of protein in 24 hours to allow participation in the study * Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better * Participants must have recovered to baseline or \< grade 2 CTCAE version (v) 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically stable on supportive therapy * Participants must not have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration * Participants must not have uncontrolled blood pressure within 28 days prior to registration as determined by the treating investigator * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to registration, if indicated * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis). Note: Participants with Graves' disease will be allowed * Participants must not have a history of pneumonitis that has required oral or IV steroids within the last 12 months prior to registration * Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System * Participants who can complete patient reported outcomes (FACT-Ga and PRO-CTCAE) questionnaires in English or Spanish must participate in the quality of life studies * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma
* Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen
* Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma
* Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 28 days prior to registration for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
* Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy. All treatment for brain metastases must have been completed at least 28 days prior to registration
* Participants must have disease progression or intolerance to frontline standard of care (SOC) chemotherapy plus either nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor. Peri-operative chemotherapy plus nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor will count as one line if disease progression occurs while on the therapy or within 6 months of completing the chemotherapy plus nivolumab or pembrolizumab or other PD-1/PD-L1 inhibitor cycle
* Participants must not have received more than one prior line of systemic therapy
* Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of ≥ 7 days prior to registration
* Participants must not have prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agent including events like pneumonitis, myocarditis, renal failure, Guillain barre syndrome, or myasthenia gravis. Participants with endocrinopathy events leading or not to replacement steroids, thyroid hormone, insulin, or cortisol are eligible
* Participants must not have received a live attenuated vaccination within 28 days prior to registration
* Participants must not have had a major surgery within 28 days or subcutaneous venous access device placement within 7 days prior registration
* Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator. Any participants with postoperative bleeding complications or wound complications from a surgical procedure performed in the last eight weeks should be excluded
* Participants must not have plans to undergo elective or planned major surgery during the clinical trial
* Participants must not have active bleeding or prior history of gastrointestinal (GI) perforation, fistula or significant GI bleeding (requiring transfusion, endoscopic or surgical intervention) within 84 days prior to registration
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, investigational agents, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
* Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
* Participants must not have a history of grade 3 or 4 immunotherapy related toxicities with the exception of hormonal abnormalities like thyroiditis or thyroid derangements
* Participants must be ≥ 18 years old
* Participants must have Zubrod Performance Status of 0-2
* Participants must have a complete medical history and physical exam within 28 days prior to registration
* Leukocytes ≥ 2 x 10\^3/uL (within 28 days prior to registration)
* Absolute neutrophil count ≥ 1.2 x 10\^3/uL (within 28 days prior to registration)
* Hemoglobin ≥ 9.0 g/dL (within 28 days prior to registration)
* Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) (unless liver metastases are present, in which case they must be ≤ 5 x ULN)
* Participants must have a creatinine ≤ 1.5 x the institutional ULN OR calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
* Participants' urinary protein must be ≤ 1+ on dipstick or routine urinalysis (UA) within 28 days of registration. Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+, then a 24-hour urine is to be collected and demonstrate \< 1000 mg of protein in 24 hours to allow participation in the study
* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better
* Participants must have recovered to baseline or \< grade 2 CTCAE version (v) 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically stable on supportive therapy
* Participants must not have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration
* Participants must not have uncontrolled blood pressure within 28 days prior to registration as determined by the treating investigator
* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration
* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to registration, if indicated
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis). Note: Participants with Graves' disease will be allowed
* Participants must not have a history of pneumonitis that has required oral or IV steroids within the last 12 months prior to registration
* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
* Participants who can complete patient reported outcomes (FACT-Ga and PRO-CTCAE) questionnaires in English or Spanish must participate in the quality of life studies
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Anwaar Saeed

PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Study Locations (Sites)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Kaiser Permanente-Anaheim

Anaheim, California, 92806

United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, 91706

United States

Kaiser Permanente-Bellflower

Bellflower, California, 90706

United States

Kaiser Permanente Dublin

Dublin, California, 94568

United States

Kaiser Permanente-Fontana

Fontana, California, 92335

United States

Kaiser Permanente-Fremont

Fremont, California, 94538

United States

Kaiser Permanente-Fresno

Fresno, California, 93720

United States

Kaiser Permanente South Bay

Harbor City, California, 90710

United States

Kaiser Permanente-Irvine

Irvine, California, 92618

United States

Keck Medicine of USC Koreatown

Los Angeles, California, 90020

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

United States

Los Angeles General Medical Center

Los Angeles, California, 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Kaiser Permanente West Los Angeles

Los Angeles, California, 90034

United States

Kaiser Permanente-Modesto

Modesto, California, 95356

United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663

United States

Kaiser Permanente-Oakland

Oakland, California, 94611

United States

Kaiser Permanente-Ontario

Ontario, California, 91761

United States

Kaiser Permanente - Panorama City

Panorama City, California, 91402

United States

Kaiser Permanente-Riverside

Riverside, California, 92505

United States

Kaiser Permanente-Roseville

Roseville, California, 95661

United States

Kaiser Permanente Downtown Commons

Sacramento, California, 95814

United States

Kaiser Permanente-South Sacramento

Sacramento, California, 95823

United States

Kaiser Permanente-San Diego Zion

San Diego, California, 92120

United States

Kaiser Permanente-San Francisco

San Francisco, California, 94115

United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119

United States

Kaiser Permanente San Leandro

San Leandro, California, 94577

United States

Kaiser Permanente-San Marcos

San Marcos, California, 92078

United States

Kaiser San Rafael-Gallinas

San Rafael, California, 94903

United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051

United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403

United States

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080

United States

Kaiser Permanente-Vallejo

Vallejo, California, 94589

United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596

United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, 91367

United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909

United States

Memorial Hospital North

Colorado Springs, Colorado, 80920

United States

Beebe South Coastal Health Campus

Millville, Delaware, 19967

United States

Helen F Graham Cancer Center

Newark, Delaware, 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

United States

Beebe Health Campus

Rehoboth Beach, Delaware, 19971

United States

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

Hawaii Cancer Care - Westridge

'Aiea, Hawaii, 96701

United States

The Queen's Medical Center - West Oahu

'Ewa Beach, Hawaii, 96706

United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813

United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813

United States

Queen's Medical Center

Honolulu, Hawaii, 96813

United States

Straub Clinic and Hospital

Honolulu, Hawaii, 96813

United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817

United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, 96819

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864

United States

Rush - Copley Medical Center

Aurora, Illinois, 60504

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

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

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451

United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

Mercyhealth Javon Bea Hospital - Rockton

Rockford, Illinois, 61103

United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, 61114

United States

Memorial Hospital East

Shiloh, Illinois, 62269

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

Mission Cancer and Blood - Ankeny

Ankeny, Iowa, 50023

United States

Saint Anthony Regional Hospital

Carroll, Iowa, 51401

United States

Mercy Hospital

Cedar Rapids, Iowa, 52403

United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309

United States

Broadlawns Medical Center

Des Moines, Iowa, 50314

United States

Trinity Regional Medical Center

Fort Dodge, Iowa, 50501

United States

Saint Joseph Hospital East

Lexington, Kentucky, 40509

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

United States

UPMC Western Maryland

Cumberland, Maryland, 21502

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

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

Hurley Medical Center

Flint, Michigan, 48503

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Henry Ford Health Providence Novi Hospital

Novi, Michigan, 48374

United States

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Community Medical Center

Missoula, Montana, 59804

United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123

United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

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

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Glens Falls Hospital

Glens Falls, New York, 12801

United States

University of Rochester

Rochester, New York, 14642

United States

Cone Health Cancer Center at Asheboro

Asheboro, North Carolina, 27203

United States

Randolph Health Cancer Center

Asheboro, North Carolina, 27203

United States

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, 27215

United States

Cone Health Cancer Center

Greensboro, North Carolina, 27403

United States

Cone Health Cancer Center at Drawbridge Parkway

Greensboro, North Carolina, 27410

United States

Annie Penn Memorial Hospital

Reidsville, North Carolina, 27320

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

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

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109

United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

United States

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

Ralph H Johnson VA Medical Center

Charleston, South Carolina, 29401

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

United States

Ben Taub General Hospital

Houston, Texas, 77030

United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

United States

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, 54154

United States

Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin, 53081

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Anwaar Saeed, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

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 Date2024-06-24

Study Completion Date2027-10-31

Study Record Updates

Study Start Date2024-06-24

Study Completion Date2027-10-31

Terms related to this study

Additional Relevant MeSH Terms

Advanced Esophageal Adenocarcinoma
Advanced Gastric Adenocarcinoma
Advanced Gastroesophageal Junction Adenocarcinoma
Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Gastric Cancer AJCC v8
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
Clinical Stage IV Gastric Cancer AJCC v8
Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Metastatic Esophageal Adenocarcinoma
Metastatic Gastric Adenocarcinoma
Metastatic Gastroesophageal Junction Adenocarcinoma
Unresectable Esophageal Adenocarcinoma
Unresectable Gastric Adenocarcinoma
Unresectable Gastroesophageal Junction Adenocarcinoma