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NCT03803553 · ClinicalTrials.gov registry record · Phase 3
Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer
A Phase 3 study of Stage III Colon Cancer and Metastatic Colon Cancer, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 3
- Study locations
NCT03803553: Recruiting Phase 3 study of Stage III Colon Cancer and Metastatic Colon Cancer, sponsored by Massachusetts General Hospital.
NCT03803553 is a Phase 3 study of Stage III Colon Cancer and Metastatic Colon Cancer that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 400 participants, below the 750-participant average among 6 other Stage III Colon Cancer trials with a reported enrollment target (47% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03803553, a Phase 3 study of Stage III Colon Cancer and Metastatic Colon Cancer, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 3
- Study locations
Study 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
Primary Outcome
Disease-free survival (DFS) between ctDNA-positive patients treated with additional treatment of FOLFIRI and ctDNA-positive patients who are untreated
Conditions Studied
Interventions
- DRUG FOLFIRI Protocol
- OTHER ACTIVE SURVEILLANCE
- DRUG Nivolumab Protocol
- DRUG Encorafenib/Binimetinib/Cetuximab Protocol
- DRUG Trastuzumab + Pertuzumab
Study Locations (3)
New York
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medical College - New York
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2020-04-16 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What NCT03803553 shows while recruiting
NCT03803553 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 750-participant average among 6 other Stage III Colon Cancer trials with a reported enrollment target (47% lower).
The record links to 2 conditions, with Stage III Colon Cancer appearing as the primary indexed condition, and to 5 interventions - of which FOLFIRI Protocol is the first listed.
NCT03803553 reports a single indexed study location in New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03803553 about?
NCT03803553 is a clinical study titled "Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer". 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/Bin...
What is the current status of trial NCT03803553?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2020-04-16. Estimated completion is 2027-12.
What conditions does trial NCT03803553 study?
This clinical trial studies the following conditions: Stage III Colon Cancer, Metastatic Colon Cancer.
What interventions are being tested in trial NCT03803553?
The interventions under investigation include: FOLFIRI Protocol (DRUG), ACTIVE SURVEILLANCE (OTHER), Nivolumab Protocol (DRUG), Encorafenib/Binimetinib/Cetuximab Protocol (DRUG), Trastuzumab + Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT03803553?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03803553 being conducted?
This trial has 3 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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