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Recruiting Phase 3 NCT03803553

Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

Trial Parameters

Condition Metastatic Colon Cancer
Sponsor Massachusetts General Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 400
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-04-16
Completion 2026-12
Interventions
FOLFIRI ProtocolACTIVE SURVEILLANCENivolumab Protocol

Brief 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 Criteria

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 constitutes appropriate standard therapy in the opinion of the treating physician. * Participants must not have received prior neoadjuvant chemotherapy. * Age ≥18 years. * ECOG performance status ≤1. * Life expectancy of greater than 3 months. * Participants must have normal organ and marrow function as defined below: * leukocytes ≥3,000/mcL * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/ mcL

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