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

This phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

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.

In order to participate you must meet the following criteria:

• Have an ECOG performance status of 0 or 1.
• Have histologically/pathologically confirmed colon adenocarcinoma.
• Have no radiographic evidence of overt metastatic disease within 28 days prior to study entry.

You will be excluded from the study if any of the following criteria apply to you:

• Have colon cancer histology other than adenocarcinoma.
• Have pathologic, clinical, or radiologic overt evidence of metastatic disease.
• Have tumor-related bowel perforation.
• Have a history of prior invasive colon malignancy, regardless of disease-free interval.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.