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RECRUITING

NCT05673148

PHASE3

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

364

Start Date

2023-10-09

Completion Date

2032-08-12

Last Updated

2026-04-07

Healthy Volunteers

Conditions

Metastatic Colorectal Adenocarcinoma Stage IV Colorectal Cancer AJCC v8

Interventions

PROCEDURE

Stereotactic Ablative Radiotherapy

Undergo SABR

PROCEDURE

Resection

undergo surgical resection

PROCEDURE

Microwave Ablation

undergo microwave ablation

DRUG

Chemotherapy

Receive SOC chemotherapy

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET scan

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: * N/A

Locations (183)

Kingman Regional Medical Center

Kingman, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Beebe Medical Center

Lewes, Delaware, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Springs

Coral Springs, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

UM Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

University of Illinois

Chicago, Illinois, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Greater Regional Medical Center

Creston, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Baptist Health Louisville

Louisville, Kentucky, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Henry Ford Health Providence Novi Hospital

Novi, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, United States

Baptist Cancer Center-Grenada

Grenada, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, United States

Parkland Health Center - Farmington

Farmington, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Renown Regional Medical Center

Reno, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

The New York Hospital Medical Center of Queens

Flushing, New York, United States

Northwell Health Physicians Partners Radiation Medicine at Queens

Forest Hills, New York, United States

Northwell Health Cancer Institute at Huntington

Greenlawn, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Northern Westchester Hospital

Mount Kisco, New York, United States

Mount Sinai West