Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study
This study tests whether adding a specialized treatment called total ablative therapy (which destroys cancer tumors) to standard chemotherapy works better than chemotherapy alone for colorectal cancer that has spread to a limited number of sites in the body. Patients will be randomly assigned to receive either standard chemotherapy or standard chemotherapy plus the additional ablative therapy.
Key Objective:The trial is testing whether combining total ablative therapy with standard chemotherapy can improve survival and cure rates for patients with limited metastatic colorectal cancer.
Who to Consider:Patients with colorectal adenocarcinoma that has spread to 4 or fewer sites in the body and who are willing to consider an intensive combined treatment approach should consider enrolling.
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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.
Eligibility 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