Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
Patients who are receiving additional investigational therapy or on another investigational protocol
Patients who have confirmed metastatic disease per CT.
Patients who are unable to get any standard adjuvant therapy
Patients who have received more than 6 months of standard adjuvant therapy at the time of study entry.
Trial design
Treatments tested in this trial
- FOLFIRI Protocol
- ACTIVE SURVEILLANCE
- Nivolumab Protocol
- Encorafenib/Binimetinib/Cetuximab Protocol
- Trastuzumab + Pertuzumab
Treatment groups
400 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Stand Up To Cancer
Collaborator
Source ClinicalTrials.gov