Actively Recruiting
Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer
Led by Massachusetts General Hospital · Updated on 2026-05-01
400
Participants Needed
3
Research Sites
52 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
Researchers are evaluating different treatment options for people with metastatic colon cancer that has been surgically removed at Stage III. The study compares additional therapy versus active surveillance based on a blood test detecting circulating tumor DNA (ctDNA), which may indicate micro-metastatic disease and risk of cancer recurrence. The study also includes groups receiving targeted therapies like nivolumab, encorafenib/binimetinib/cetuximab, and trastuzumab plus pertuzumab, with the goal of reducing cancer recurrence and improving health outcomes. Participants undergo pre-screening that includes tumor assessment, sequencing, and blood tests for ctDNA and genetic markers such as microsatellite instability (MSI) and BRAF mutation. Eligible participants are randomized into groups receiving FOLFIRI chemotherapy, active surveillance, or targeted treatments depending on their ctDNA and genetic status. Treatments vary in schedule and duration, including FOLFIRI given every two weeks for up to 24 weeks, nivolumab every four weeks for up to 48 weeks, oral and infusion therapy for BRAF-mutant tumors over 24 weeks, and trastuzumab plus pertuzumab infusions every 21 days for up to 8 cycles. Throughout the study, participants will have regular imaging scans, tumor marker tests, and blood draws for ctDNA monitoring. These assessments occur frequently in the first months and continue long-term to track disease-free survival and ctDNA clearance. Researchers will analyze disease recurrence, ctDNA changes, overall survival, and health status over a follow-up period of up to five years. Safety and health are monitored continuously, with additional scans or tests as needed, to understand how these treatments may affect outcomes in metastatic colon cancer patients.
CONDITIONS
Brief 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 (T1-T4, N1-2, M0)
- Complete tumor removal with documented en bloc RO resection if tumor adherent to structures
- Tumor confined to colon; no rectal involvement
- Completed standard adjuvant chemotherapy (FOLFOX, CAPOX, or 5FU analog) as per treating physician
- No prior neoadjuvant chemotherapy
- 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 specific blood counts and liver/kidney tests
- Women of childbearing potential must have negative pregnancy test
- Willingness to use effective contraception or abstain from heterosexual activity during and after treatment
- Documentation of microsatellite instability status
- Positive circulating tumor DNA (ctDNA) test using Guardant Reveal after adjuvant therapy for ctDNA-positive cohort
- Ability to understand and sign informed consent
- For HER2 cohort: HER2 overexpression/amplification confirmed, liver enzymes within limits, LVEF ≥ 55%, contraceptive use for childbearing potential
You will not qualify if you...
- Receiving other investigational therapies or enrolled in another investigational protocol
- Confirmed metastatic disease by CT
- Unable to receive standard adjuvant therapy
- More than 6 months of standard adjuvant therapy received
- Received anticancer therapy other than standard adjuvant within 30 days prior to study
- MSI-high or BRAF V600E mutation patients excluded from certain arms
- Uncontrolled illnesses including active infections, heart failure, unstable angina, cardiac arrhythmias
- Psychiatric or substance abuse disorders interfering with compliance
- Pregnant or breastfeeding participants in ctDNA positive cohort
- Additional progressing malignancies requiring treatment
- Active infections requiring systemic therapy
- For nivolumab cohort: immunodeficiency, recent steroids, active TB, hypersensitivity, autoimmune disease
- For BRAF mutant cohort: prior BRAF or MEK inhibitors, hypersensitivity, significant cardiac or gastrointestinal conditions, recent surgery or radiotherapy
- Serious cardiac illnesses or uncontrolled arrhythmias for HER2 cohort
- Concurrent serious diseases interfering with treatment
- Known HIV positive with exceptions, hepatitis B or C under care
- Live vaccine received within 30 days of therapy start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 24 to 48 weeks depending on assigned treatment
Participants receive assigned treatment based on their ctDNA status and other genetic markers. Treatment options include FOLFIRI chemotherapy, Nivolumab immunotherapy, Encorafenib/Binimetinib/Cetuximab targeted therapy, or Trastuzumab and Pertuzumab infusions. Those in active surveillance do not receive further treatment but are monitored.
Up to 12 cycles of treatment with visits every 14, 21, or 28 days depending on regimen
Duration - Up to 3 years with decreasing frequency over time
Participants are monitored through active surveillance with imaging scans, tumor marker tests, and ctDNA blood draws to detect cancer recurrence and assess health status.
Monthly visits for the first 6 months, then every 3 months for up to 3 years, and every 6 months thereafter
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
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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