Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)
Objective
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
Eligibility
Key Inclusion Criteria:
- ECOG 0 or 1
- Must have histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection
- No radiographic evidence of overt metastatic disease within 45 days
- Distal tumor must be ≥ 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen
- Curative resection
- Tumor must be documented as microsatellite stable or have intact mismatch repair proteins
- Treating investigator must deem patient a candidate for all potential agents used in this trial (5fu, LV, Oxaliplatin and Irinotecan)
- Interval between surgery (post-operative Day 7) and step 1/study entry must be no more than 60 days
- Adequate hematologic/hepatic/renal function with 28 days before study entry
- Pregnancy test done within 14 days for WOCBP
Key Exclusion Criteria:
- Colon cancer histology other than adenocarcinoma
- Pathologic, clinical, or radiologic overt evidence of metastatic disease
- Tumor-related bowel perforation
- History of prior invasive colon malignancy, regardless of disease-free interval
- History of bone marrow or solid organ transplantation
- Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer
- Other invasive malignancy within 5 years before step 1
- Patients with known history of current symptoms of cardiac disease, or history of treatment with cardiotoxic agents
- Sensory of motor neuropathy ≥ grade 2
NCT ID
NCT05174169
