RecruitingPhase 3NCT03803553

Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

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

Sponsor

Massachusetts General Hospital

Enrollment

400 participants

Start Date

Apr 16, 2020

Study Type

INTERVENTIONAL

Conditions

Metastatic Colon Cancer Stage III Colon Cancer

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether traces of cancer cells remaining in the blood after colon cancer surgery — called circulating tumor DNA (ctDNA) — can predict which patients are most likely to have their cancer come back, and whether this information can guide who needs additional chemotherapy after surgery. **You may be eligible if...** - You have been diagnosed with stage III colon cancer (cancer has spread to nearby lymph nodes but not distant organs) that has been surgically removed - Your surgeon removed all visible cancer (complete resection) - The tumor is entirely in the colon (no rectal involvement) **You may NOT be eligible if...** - Your cancer was not completely removed by surgery - Your cancer involves the rectum - You are unable or unwilling to provide blood samples for ctDNA testing - You have other serious health conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.