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Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

Colon cancer
All genders
person-wave 18+
Recruiting now
More information  


Principal Investigator: Jacob Elkon, MD

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.

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Study details

Inclusion Criteria
  • The patient must have an ECOG performance status of 0 or 1.
  • Patients must have histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria.
  • No radiographic evidence of overt metastatic disease within 28 days prior to study entry
Exclusion Criteria
  • Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).
  • Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.
  • Tumor-related bowel perforation.
Study Requirements

This study contains two cohorts, the ctDNA negative cohort and the ctDNA positive cohort based on the post-operation ctDNA test results. A randomized phase II/III study will be conducted within each cohort. Cohort A: patients will be randomized into immediate treatment arm (Arm 1) and delayed treatment arm (Arm 2). The primary endpoint for phase II of Cohort A is time to ctDNA (+ve) status (TTPos) and the primary endpoint for phase III of Cohort A is disease-free survival. Patients on Arm 2 who turned ctDNA (+ve) will cross over to Cohort B study. Cohort B (ctDNA +ve): patients will be randomized to receive either FP (5-FU/ capecitabine + oxaliplatin, Arm 3) or FOLFIRINOX (5-FU + oxaliplatin + irinotecan, Arm 4) for 6 months. The primary endpoint for both phase II and III of Cohort B is disease-free survival.

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