Table 1 Eligibility Criteria
1. Age ≥ 18 years. |
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2. Eastern Cooperative Oncology Group Performance status of 0–2. |
3. Histologically confirmed metastatic colorectal adenocarcinoma. |
4. No known microsatellite instable (MSI) tumor. |
5. No known BRAF V600E mutation. |
6. No known peritoneal and/or omental metastases. |
7. Primary tumor is already resected or amenable to resection. |
8. 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. Single sites include: a. Each hemi-liver (right and left). b. Each lobe of the lungs. c. Each adrenal gland. d. Lymph nodes amenable to a single resection or treatment in a single stereotactic ablative radiation therapy (SABR) field. e. Bone metastases amenable to treatment in a single SABR field. |
9. Liver-only metastatic disease is not permitted. |
10. Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and/or SABR. SABR is required for at least one lesion. |
11. Measurable disease per RECIST v1.1. |
12. No overt evidence of disease progression during systemic therapy prior to registration. |
13. Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined. |
14. Received first-line systemic therapy for metastatic disease for a minimum of 16 weeks and a maximum of 26 weeks. |
15. Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease. |
16. No pregnant or nursing patients. |
17. No other planned concurrent investigational agents while on study. |
18. Required initial laboratory values: a. Absolute neutrophil count ≥ 1,500/mm3 b. Platelet count ≥ 50,000/mm3 c. Creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min d. Total bilirubin ≤ 1.5 x ULN e. AST(SGOT)/ALT(SGPT) ≤ 3.0 x ULN– if metastatic liver disease, ≤ 5 x ULN |