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

Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.

Sponsor: NRG Oncology

https://clinicaltrials.gov/ct2/show/NCT05174169

• Have confirmed colon adenocarcinoma (T1-3, N1/N1c).
• No radiographic evidence of overt metastatic disease within 28 days prior to study entry.
• The distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection.
• The patient must have had an en bloc complete gross resection of tumor (curative resection).
• Tumor must be documented as microsatellite stable or have intact mismatch repair proteins. Patients whose tumors are MSI-H or dMMR are excluded.
• The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan).
• The interval between surgery (post-operative Day 7) and study entry must be no more than 60 days.