Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer
Massachusetts General Hospital
Summary
This research study is comparing two standard of care treatment options based on blood test results for participants who have metastatic colon cancer. The names of the potential treatments involved in this study are: * Active surveillance * FOLFIRI treatment * Nivolumab treatment * Encorafenib/Binimetinib/Cetuximab treatment * Trastuzumab + Pertuzumab
Description
The FDA (the U.S. Food and Drug Administration) has approved FOLFIRI, comprised of Irinotecan, Leucovorin, and 5-Fluorouracil, as a treatment option for metastatic colon cancer in the Stage IV setting. * After diagnosis and surgical removal of tumors, individuals with metastatic colon cancer commonly receive what is called adjuvant chemotherapy treatment, commonly utilizing treatment plans called FOLFOX, CAPOX, or therapy with 5-Fluorouracil. * If all the cancer is not killed, the investigators may be able to detect tumor in the blood called circulating tumor DNA (ctDNA). This is genetic mate…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically confirmed resected Stage III adenocarcinoma of the colon. Any T \[Tx, T1, T2, T3, or T4-\], N1-2M0. * Participants must have completely resected disease. In patients with tumor adherent to adjacent structures, en block RO resection must be documented. * Entire tumor must be in the colon (rectal involvement is excluded). * Participants must have completed standard adjuvant chemotherapy per the discretion of the treating physician. Standard therapy includes FOLFOX, CAPOX, or therapy with 5FU analog alone will be permitted if it constit…
Interventions
- DrugFOLFIRI Protocol
FOLFIRI cycle will be two weeks (14 days) long, with FOLFIRI administered on Days 1-3. Participants will receive up to 12 two-week cycles (for a total of 24 weeks) of FOLFIRI chemotherapy.
- OtherACTIVE SURVEILLANCE
Will be followed with observation and monitoring with imaging, tumor markers, and ctDNA collections
- DrugNivolumab Protocol
Nivolumab cycle will be four weeks (28 days) long, with Nivolumab administered on day 1. Participants will receive up to 12 four-week cycles (for a total of 48 weeks) of Nivolumab treatment.
- DrugEncorafenib/Binimetinib/Cetuximab Protocol
Encorafenib/Binimetinib will be taken orally every day and Cetuximab will be administered intravenously on day 1 of each cycle. Cycles are 14 days long. Participants will receive up to 12 two-week cycles (for a total of 24 weeks) of Encorafenib/Binimetinib/Cetuximab.
- DrugTrastuzumab + Pertuzumab
Trastuzumab (Herceptin) is received by intravenous administration and Pertuzumab is received intravenously by infusion on Day 1 of each cycle. Cycles are 21 days long. Participants will receive up to 8 cycles of Trastuzumab and Pertuzumab.
Locations (3)
- Massachusetts General HospitalBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Weill Cornell Medical CollegeNew York, New York