Program Status
RecruitingPhase
Phase 3Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
ChemotherapyTags
MSS/ MMRpComments
Trial for patients with colorectal cancer that has spread to up to 4 body sites (newly diagnosed oligometastatic colorectal cancer, limited metastatic).
Patients are randomized to receive the standard of care (SOC) (systemic therapy alone, chemotherapy regimens) OR such standard of care with the addition of TAT (total ablative therapy) for the metastatic lesions. That is, along with receiving chemotherapy, the mets will be ablated (eliminated) with intensive radiotherapy, called stereotactic ablative radiotherapy (SABR), with or without surgical resection and/or microwave ablation (MWA).
Key inclusion criteria: Primary tumor is already resected OR primary tumor is surgically amenable to resection; 4 or less metastatic sites; liver-only disease is not admitted (For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible).
See other inclusion and exclusion criteria.
Location | Location Status |
---|---|
United States | |
Kingman Regional Medical Center Kingman, Arizona 86401 |
Recruiting |
Mayo Clinic Hospital in Arizona Phoenix, Arizona 85054 |
Recruiting |
Tower Cancer Research Foundation Beverly Hills, California 90211 |
Recruiting |
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California 92612 |
Recruiting |
Cedars Sinai Medical Center Los Angeles, California 90048 |
Recruiting |
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California 92868 |
Recruiting |
University of California Davis Comprehensive Cancer Center Sacramento, California 95817 |
Active, not recruiting |
Beebe Medical Center Lewes, Delaware 19958 |
Recruiting |
Beebe South Coastal Health Campus Millville, Delaware 19967 |
Recruiting |
Helen F Graham Cancer Center Newark, Delaware 19713 |
Recruiting |
Medical Oncology Hematology Consultants PA Newark, Delaware 19713 |
Recruiting |
Christiana Care Health System-Christiana Hospital Newark, Delaware 19718 |
Recruiting |
Beebe Health Campus Rehoboth Beach, Delaware 19971 |
Recruiting |
Sibley Memorial Hospital Washington, District of Columbia 20016 |
Suspended |
University of Florida Health Science Center - Gainesville Gainesville, Florida 32610 |
Recruiting |
Miami Cancer Institute Miami, Florida 33176 |
Recruiting |
Grady Health System Atlanta, Georgia 30303 |
Recruiting |
Emory Proton Therapy Center Atlanta, Georgia 30308 |
Recruiting |
Emory University Hospital Midtown Atlanta, Georgia 30308 |
Recruiting |
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia 30322 |
Recruiting |
Emory Saint Joseph's Hospital Atlanta, Georgia 30342 |
Recruiting |
Saint Luke's Cancer Institute - Boise Boise, Idaho 83712 |
Recruiting |
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho 83619 |
Recruiting |
Saint Luke's Cancer Institute - Meridian Meridian, Idaho 83642 |
Recruiting |
Saint Luke's Cancer Institute - Nampa Nampa, Idaho 83687 |
Recruiting |
Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho 83301 |
Recruiting |
University of Illinois Chicago, Illinois 60612 |
Recruiting |
Mission Cancer and Blood - Ankeny Ankeny, Iowa 50023 |
Recruiting |
Mercy Cancer Center-West Lakes Clive, Iowa 50325 |
Recruiting |
Mission Cancer and Blood - West Des Moines Clive, Iowa 50325 |
Recruiting |
Greater Regional Medical Center Creston, Iowa 50801 |
Recruiting |
Iowa Methodist Medical Center Des Moines, Iowa 50309 |
Recruiting |
Mission Cancer and Blood - Des Moines Des Moines, Iowa 50309 |
Recruiting |
Mercy Medical Center - Des Moines Des Moines, Iowa 50314 |
Recruiting |
Mission Cancer and Blood - Laurel Des Moines, Iowa 50314 |
Recruiting |
Mercy Medical Center-West Lakes West Des Moines, Iowa 50266 |
Recruiting |
University of Kentucky/Markey Cancer Center Lexington, Kentucky 40536 |
Active, not recruiting |
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland 21287 |
Recruiting |
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan 48106 |
Recruiting |
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan 48114 |
Recruiting |
Trinity Health Medical Center - Brighton Brighton, Michigan 48114 |
Recruiting |
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan 48188 |
Recruiting |
Trinity Health Medical Center - Canton Canton, Michigan 48188 |
Recruiting |
Chelsea Hospital Chelsea, Michigan 48118 |
Recruiting |
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan 48118 |
Recruiting |
Corewell Health Dearborn Hospital Dearborn, Michigan 48124 |
Recruiting |
Henry Ford Hospital Detroit, Michigan 48202 |
Recruiting |
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan 48336 |
Recruiting |
Genesys Hurley Cancer Institute Flint, Michigan 48503 |
Recruiting |
Hurley Medical Center Flint, Michigan 48503 |
Recruiting |
University of Michigan Health - Sparrow Lansing Lansing, Michigan 48912 |
Recruiting |
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan 48154 |
Recruiting |
Henry Ford Health Providence Novi Hospital Novi, Michigan 48374 |
Suspended |
Corewell Health William Beaumont University Hospital Royal Oak, Michigan 48073 |
Recruiting |
Henry Ford Health Providence Southfield Hospital Southfield, Michigan 48075 |
Recruiting |
Corewell Health Beaumont Troy Hospital Troy, Michigan 48085 |
Recruiting |
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan 48197 |
Recruiting |
Sanford Joe Lueken Cancer Center Bemidji, Minnesota 56601 |
Recruiting |
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi 39705 |
Recruiting |
Baptist Cancer Center-Grenada Grenada, Mississippi 38901 |
Recruiting |
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi 38652 |
Recruiting |
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi 38655 |
Recruiting |
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi 38671 |
Recruiting |
Mercy Hospital Saint Louis Saint Louis, Missouri 63141 |
Recruiting |
Mercy Hospital Springfield Springfield, Missouri 65804 |
Recruiting |
Billings Clinic Cancer Center Billings, Montana 59101 |
Recruiting |
Benefis Sletten Cancer Institute Great Falls, Montana 59405 |
Recruiting |
Nebraska Medicine-Bellevue Bellevue, Nebraska 68123 |
Recruiting |
Nebraska Medicine-Village Pointe Omaha, Nebraska 68118 |
Recruiting |
University of Nebraska Medical Center Omaha, Nebraska 68198 |
Recruiting |
Renown Regional Medical Center Reno, Nevada 89502 |
Recruiting |
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire 03756 |
Recruiting |
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey 07920 |
Recruiting |
Memorial Sloan Kettering Monmouth Middletown, New Jersey 07748 |
Recruiting |
Memorial Sloan Kettering Bergen Montvale, New Jersey 07645 |
Recruiting |
University of New Mexico Cancer Center Albuquerque, New Mexico 87106 |
Recruiting |
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn, New York 11215 |
Recruiting |
Memorial Sloan Kettering Commack Commack, New York 11725 |
Recruiting |
The New York Hospital Medical Center of Queens Flushing, New York 11355 |
Recruiting |
Northwell Health Physicians Partners Radiation Medicine at Queens Forest Hills, New York 11375 |
Recruiting |
Northwell Health Cancer Institute at Huntington Greenlawn, New York 11740 |
Recruiting |
Northwell Health/Center for Advanced Medicine Lake Success, New York 11042 |
Recruiting |
Northern Westchester Hospital Mount Kisco, New York 10549 |
Recruiting |
Mount Sinai West New York, New York 10019 |
Recruiting |
Mount Sinai Hospital New York, New York 10029 |
Recruiting |
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York 10032 |
Recruiting |
Manhattan Eye Ear and Throat Hospital New York, New York 10065 |
Recruiting |
Memorial Sloan Kettering Cancer Center New York, New York 10065 |
Recruiting |
NYP/Weill Cornell Medical Center New York, New York 10065 |
Recruiting |
Lenox Hill Hospital New York, New York 10075 |
Recruiting |
Queens Cancer Center Rego Park, New York 11374 |
Recruiting |
University of Rochester Rochester, New York 14642 |
Recruiting |
Memorial Sloan Kettering Nassau Uniondale, New York 11553 |
Recruiting |
Westchester Medical Center Valhalla, New York 10595 |
Recruiting |
Wilmot Cancer Institute at Webster Webster, New York 14580 |
Recruiting |
Memorial Sloan Kettering Westchester West Harrison, New York 10604 |
Recruiting |
Sanford Bismarck Medical Center Bismarck, North Dakota 58501 |
Recruiting |
Sanford Broadway Medical Center Fargo, North Dakota 58122 |
Recruiting |
Sanford Roger Maris Cancer Center Fargo, North Dakota 58122 |
Recruiting |
Dayton Physicians LLC-Miami Valley South Centerville, Ohio 45459 |
Recruiting |
Miami Valley Hospital South Centerville, Ohio 45459 |
Recruiting |
MetroHealth Medical Center Cleveland, Ohio 44109 |
Recruiting |
Ohio State University Comprehensive Cancer Center Columbus, Ohio 43210 |
Recruiting |
Miami Valley Hospital Dayton, Ohio 45409 |
Recruiting |
Premier Blood and Cancer Center Dayton, Ohio 45409 |
Recruiting |
Dayton Physician LLC - Englewood Dayton, Ohio 45415 |
Recruiting |
Miami Valley Hospital North Dayton, Ohio 45415 |
Recruiting |
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio 45005-1066 |
Recruiting |
Dayton Physicians LLC-Atrium Franklin, Ohio 45005 |
Recruiting |
Miami Valley Cancer Care and Infusion Greenville, Ohio 45331 |
Recruiting |
Upper Valley Medical Center Troy, Ohio 45373 |
Recruiting |
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma 73104 |
Recruiting |
Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania 19317 |
Recruiting |
Geisinger Medical Center Danville, Pennsylvania 17822 |
Recruiting |
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania 17837 |
Recruiting |
Allegheny General Hospital Pittsburgh, Pennsylvania 15212 |
Recruiting |
West Penn Hospital Pittsburgh, Pennsylvania 15224 |
Recruiting |
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania 18711 |
Recruiting |
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota 57104 |
Recruiting |
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota 57117-5134 |
Recruiting |
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee 38120 |
Recruiting |
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee 37232 |
Recruiting |
University of Texas Health Science Center at San Antonio San Antonio, Texas 78229 |
Active, not recruiting |
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah 84112 |
Recruiting |
Valley Medical Center Renton, Washington 98055 |
Recruiting |
Langlade Hospital and Cancer Center Antigo, Wisconsin 54409 |
Recruiting |
Medical College of Wisconsin Milwaukee, Wisconsin 53226 |
Recruiting |
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin 54501 |
Recruiting |
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin 54481 |
Recruiting |
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin 54494 |
Recruiting |
Contacts
Inclusion Criteria
Inclusion Criteria:
* PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma
* PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor
* PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation
* 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
* 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
* 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.
* Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.
* 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.
* 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.
* Single sites include:
* 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
* PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration
* REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration
* REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined
* REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1
* 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)
* REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease
* REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects.
* Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required
* REGISTRATION (STEP 1): Age >= 18 years
* REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) >= 1,500/mm^3
* REGISTRATION (STEP 1): Platelet count >= 50,000/mm^3
* REGISTRATION (STEP 1): Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min
* Calculated using the Cockcroft-Gault equation
* REGISTRATION (STEP 1): Total bilirubin =< 1.5 x ULN
* REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN
* In the event of metastatic liver disease, =< 5 x ULN
* 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
* REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study
Exclusion Criteria
Exclusion Criteria:
* N/A