RECRUITING

Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study

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 III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.

Official Title

A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)

Quick Facts

Study Start:2023-01-10
Study Completion:2032-08-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05673148

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 CriteriaExclusion Criteria
  1. * PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma
  2. * PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor
  3. * PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation
  4. * PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants
  5. * PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible
  6. * PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy.
  7. * Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.
  8. * Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study.
  9. * Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and/or stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the patient must be seen by a radiation oncologist in consultation to verify eligibility.
  10. * Single sites include:
  11. * Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field
  12. * PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
  13. * PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration
  14. * REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration
  15. * REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined
  16. * REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1
  17. * REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months)
  18. * REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease
  19. * REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects.
  20. * REGISTRATION (STEP 1): Age \>= 18 years
  21. * REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
  22. * REGISTRATION (STEP 1): Absolute neutrophil count (ANC) \>= 1,500/mm\^3
  23. * REGISTRATION (STEP 1): Platelet count \>= 50,000/mm\^3
  24. * REGISTRATION (STEP 1): Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 30 mL/min
  25. * REGISTRATION (STEP 1): Total bilirubin =\< 1.5 x ULN
  26. * REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x ULN
  27. * REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility
  28. * REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study
  1. * N/A

Contacts and Locations

Study Contact

Eric D. Miller, MD, PhD
CONTACT
614-685-4922
eric.miller@osumc.edu

Study Locations (Sites)

Kingman Regional Medical Center
Kingman, Arizona, 86401
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
United States
Sibley Memorial Hospital
Washington, District of Columbia, 20016
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Grady Health System
Atlanta, Georgia, 30303
United States
Emory Proton Therapy Center
Atlanta, Georgia, 30308
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686
United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
United States
University of Illinois
Chicago, Illinois, 60612
United States
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, 50023
United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
United States
Mission Cancer and Blood - West Des Moines
Clive, Iowa, 50325
United States
Greater Regional Medical Center
Creston, Iowa, 50801
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, 50309
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
United States
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314
United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
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
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
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
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075
United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
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
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
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
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
United States
Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York, 11375
United States
Northwell Health Cancer Institute at Huntington
Greenlawn, New York, 11740
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
United States
Northern Westchester Hospital
Mount Kisco, New York, 10549
United States
Mount Sinai West
New York, New York, 10019
United States
Lenox Hill Hospital
New York, New York, 10021
United States
Mount Sinai Hospital
New York, New York, 10029
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
NYP/Weill Cornell Medical Center
New York, New York, 10065
United States
Queens Cancer Center
Rego Park, New York, 11374
United States
University of Rochester
Rochester, New York, 14642
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580
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
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
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
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
Upper Valley Medical Center
Troy, Ohio, 45373
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
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
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
Valley Medical Center
Renton, Washington, 98055
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin, 54501
United States
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, 54481
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: Alliance for Clinical Trials in Oncology

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 Date2023-01-10
Study Completion Date2032-08-12

Study Record Updates

Study Start Date2023-01-10
Study Completion Date2032-08-12

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Colorectal Adenocarcinoma
  • Stage IV Colorectal Cancer AJCC v8