OncoMatch/Clinical Trials/NCT05673148
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Is NCT05673148 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Chemotherapy for metastatic colorectal adenocarcinoma.
Treatment: Chemotherapy — This phase III trial compares the addition of total ablative therapy to the usual systemic therapy versus the usual systemic therapy alone in treating patients with advanced 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 (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. The ablative local therapy will consist of any combination of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR), surgical resection, 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. The addition of ablative local therapy to the usual approach of systemic therapy could be more effective than usual chemotherapy alone by increasing the life of patients with limited metastatic colorectal cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: MSI1 instability
No known microsatellite instable (MSI) tumor
Excluded: BRAF v600e
No known BRAF V600E mutation
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy for metastatic disease — metastatic colorectal cancer
Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 12 weeks and a maximum of 52 weeks
Cannot have received: definitive therapy including adjuvant chemotherapy
Exception: must have been completed at least 6 months prior to diagnosis of metastatic disease
Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 6 months prior to diagnosis of metastatic disease
Lab requirements
Blood counts
ANC ≥ 1,000/mm^3; Platelet count ≥ 50,000/mm^3
Kidney function
Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault equation)
Liver function
Total bilirubin ≤ 1.5 x ULN (direct bilirubin ≤ 1.5 x ULN if Gilbert's disease and FOLFIRI; direct bilirubin ≤ 3.0 x ULN if mFOLFOX6); AST/ALT ≤ 3.0 x ULN (≤ 5 x ULN if metastatic liver disease)
Cardiac function
NYHA Functional Classification class 2B or better
ANC ≥ 1,000/mm^3; Platelet count ≥ 50,000/mm^3; Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min; Total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 3.0 x ULN (≤ 5 x ULN if metastatic liver disease); NYHA Functional Classification class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Kingman Regional Medical Center · Kingman, Arizona
- Mayo Clinic Hospital in Arizona · Phoenix, Arizona
- Tower Cancer Research Foundation · Beverly Hills, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- Cedars-Sinai Medical Center · Los Angeles, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05673148 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior definitive therapy including adjuvant chemotherapy disqualifies patients from enrollment.
Are patients with MSI1 alterations eligible?
No. MSI1 instability is an exclusion criterion.
Are patients with BRAF alterations eligible?
No. BRAF v600e is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages