A Phase II Study of Different Treatments for People with Stage III Colon Cancer Who Received Chemotherapy and Are Having Testing for Tumor DNA in the Blood

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Full Title

Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer

Purpose

After people receive chemotherapy for colon cancer, doctors may be able to detect tumor DNA in the blood (“circulating tumor DNA” or ctDNA). If there is ctDNA in the blood, a patient’s cancer may be more likely to come back. It is standard for people with ctDNA in their blood to be monitored (“active surveillance”), but investigators would like to know if immediate treatment of these patients can prevent cancer recurrence.

In this study, researchers are comparing four different approaches for people who have completed chemotherapy for stage III colon cancer and are undergoing ctDNA testing:

  • Active surveillance
  • FOLFIRI chemotherapy (a combination of the drugs irinotecan, leucovorin, and 5-fluorouracil)
  • Nivolumab immunotherapy (only for patients with a special subtype of colon cancer called microsatellite unstable disease)
  • A combination of the drugs encorafenib, binimetinib, and cetuximab (only for patients whose colon cancer has a mutation in the BRAF gene, called a BRAF V600E mutation)

The investigators will check whether there are differences in cancer recurrence between patients receiving the first two approaches. They will also check the rate of recurrence for patients with tumors that make them eligible to receive the third or fourth approaches.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have stage III colon cancer and just finished receiving their first course of chemotherapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Rona Yaeger at 646-888-5109.

Protocol

22-068

Phase

III

Disease Status

Newly Diagnosed

Investigator

Luis Diaz