Colon Cancer NRG-GI005

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.

Eligibility Criteria:

• • Histologically/pathologically confirmed stage IIA adenocarcinoma of the colon with at least 12 lymph nodes examined at the time of surgical resection.
  • Appropriate for active surveillance (i.e., no adjuvant chemotherapy) at the discretion of the evaluating oncologist based on current practice patterns.
  • The distal extent of the tumor must be ≥12 cm from the anal verge on pre-surgical endoscopy.
  • The patient must have had an en bloc complete gross resection of tumor as definitive surgical cancer treatment within 14 to 60 days of study randomization.
  • Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 2 and receive capecitabine.
  • No History of prior invasive colon malignancy, regardless of disease-free interval.
  • No Colon cancer histology other than adenocarcinoma

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut, Midstate Medical Center, William Backus Hospital