NCT03803553 is a Phase 3 clinical trial of FOLFIRI Protocol in Metastatic Colon Cancer, sponsored by Massachusetts General Hospital.

Who is sponsoring NCT03803553?

NCT03803553 is sponsored by Massachusetts General Hospital.

What drugs are being tested in NCT03803553?

Interventions in NCT03803553: FOLFIRI Protocol, ACTIVE SURVEILLANCE, Nivolumab Protocol, Encorafenib/Binimetinib/Cetuximab Protocol, Trastuzumab + Pertuzumab.

What condition does NCT03803553 study?

NCT03803553 studies Metastatic Colon Cancer, Stage III Colon Cancer.

Is NCT03803553 still recruiting?

NCT03803553 is currently recruiting now. Last updated 27 April 2026.

Last reviewed 2026-04-27 · How we verify

NCT03803553

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 27 April 2026

What this trial tests

Phase 3 trial testing FOLFIRI Protocol in Metastatic Colon Cancer in 400 participants. Currently enrolling.

Timeline

16 April 2020

Primary endpoint
1 December 2026

1 December 2027

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	400
Start date	16 April 2020
Primary completion	1 December 2026
Estimated completion	1 December 2027
Sites	3 locations across United States

Drugs / interventions tested

FOLFIRI Protocol — full drug profile →
ACTIVE SURVEILLANCE
Nivolumab Protocol — full drug profile →
Encorafenib/Binimetinib/Cetuximab Protocol — full drug profile →
Trastuzumab + Pertuzumab — full drug profile →

Conditions studied

Metastatic Colon Cancer — all drugs for Metastatic Colon Cancer →
Stage III Colon Cancer — all drugs for Stage III Colon Cancer →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Metastatic Colon Cancer or Stage III Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Disease-free survival (DFS)
Time frame: 5 years
Disease-free survival (DFS) between ctDNA-positive patients treated with additional treatment of FOLFIRI and ctDNA-positive patients who are untreated
Clearance rate of ctDNA
Time frame: 7 Months
Compare the clearance rate of ctDNA in ctDNA-positive patients between patients treated with additional treatment of FOLFIRI and those who are untreated

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of FOLFIRI Protocol

Trials testing the same drug.

NCT06047379 — Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis · Phase 1, PHASE2 · recruiting
NCT05605509 — RP-6306 in Patients With Advanced Cancer · Phase 2 · completed
NCT05039944 — SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies · Phase 2 · terminated
NCT05084859 — A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With H · Phase 1 · terminated
NCT04247256 — A Phase 2 Trial of SCO-101 in Combination With FOLFIRI for Patients With Metastatic Colorectal Cancer (mCRC) With Acquir · Phase 1, PHASE2 · unknown

Other recruiting trials for Metastatic Colon Cancer

Currently open trials in the same condition.

NCT06202183 — Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial · NA · recruiting
NCT05848739 — A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors · Phase 1 · recruiting
NCT05714124 — Liver Embolization Approaches for Tumor Management · recruiting

Other Massachusetts General Hospital trials

Trials by the same sponsor.

NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03803553 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 27 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03803553.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing