Actively Recruiting
Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer
Led by Massachusetts General Hospital · Updated on 2026-05-01
400
Participants Needed
3
Research Sites
397 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
S
Stand Up To Cancer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed resected Stage III adenocarcinoma of the colon (any T, N1-2, M0)
- Completely resected disease, including en bloc R0 resection if tumor adherent to adjacent structures
- Tumor located entirely in the colon (no rectal involvement)
- Completed standard adjuvant chemotherapy (FOLFOX, CAPOX, or 5FU alone) as per treating physician
- No prior neoadjuvant chemotherapy received
- Age 18 years or older
- ECOG performance status 0 or 1
- Life expectancy greater than 3 months
- Normal organ and marrow function as defined by blood counts and liver/kidney tests
- Negative pregnancy test for women of childbearing potential
- Willingness to use effective contraception if of childbearing potential or male participant
- Documentation of microsatellite instability status
- Circulating tumor DNA assay meeting quality control metrics
- For ctDNA positive cohort, positive ctDNA after adjuvant therapy using Guardant Reveal assay
- Ability to understand and sign informed consent
- For HER2 cohort: HER2 overexpression/amplification confirmed, normal liver enzymes, effective contraception, and recent cardiac function evaluation with LVEF ≥ 55%
You will not qualify if you...
- Receiving other investigational therapy or enrolled in another investigational protocol
- Confirmed metastatic disease visible on CT
- Unable to receive standard adjuvant therapy
- Received more than 6 months of standard adjuvant therapy before study entry
- Received anticancer therapy other than standard adjuvant therapy within 30 days before study treatment
- MSI-high or BRAF V600E mutation patients excluded from certain arms
- Uncontrolled illness or infection, including symptomatic heart failure or unstable angina
- Psychiatric or substance abuse disorders interfering with study compliance
- Pregnant or breastfeeding for ctDNA positive cohort
- Additional progressing malignancy requiring active treatment (exceptions for some skin cancers and in situ cervical cancer)
- Active infection requiring systemic therapy
- For MSI-H cohort receiving nivolumab: immunodeficiency, recent immunosuppressive therapy, active TB, hypersensitivity to nivolumab, active autoimmune disease requiring systemic treatment, oxygen requirement, HIV with uncontrolled viral load or low CD4 count, hepatitis B or C not well controlled, recent live vaccine
- For BRAF mutant cohort: prior BRAF or MEK inhibitor therapy, hypersensitivity to study drugs, allergies to related compounds, inability to swallow study drugs, recent major surgery or radiotherapy without recovery, cardiovascular disease or conditions affecting drug absorption, neuromuscular disorders, retinal diseases, prohibited medications use, recent thromboembolic events
- Concurrent or recent other malignancies within 2 years except certain treated cancers
- Known HIV/AIDS positive or uncontrolled viral infections
- For HER2 cohort: serious cardiac illnesses, uncontrolled arrhythmias, recent myocardial infarction, poorly controlled hypertension, ventricular dysrhythmias, high-risk patients with prior chemoprevention drugs, concurrent anti-cancer treatment in other trials, severe pulmonary conditions or poorly controlled diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
Research Team
A
Aparna Parikh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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