Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study
Recruiting · NCT05673148 · Interventional (participants receive a specific treatment) · Lead sponsor: Alliance for Clinical Trials in Oncology
View the official record on ClinicalTrials.gov →Interventions studied
ChemotherapyComputed TomographyMagnetic Resonance ImagingMicrowave AblationPositron Emission TomographyResectionStereotactic Ablative Radiotherapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 39 US states.
- 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
- Baptist Health Floyd - New Albany, Indiana, 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
Showing 60 of 187 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →