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NCT03223779 · ClinicalTrials.gov registry record · Phase 1
Study of TAS-102 Plus Radiation Therapy for the Treatment of the Liver in Patients With Hepatic Metastases From Colorectal Cancer
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT03223779: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT03223779 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03223779, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This research study is studying a drug in combination with radiation therapy as a possible treatment for hepatic metastases from colorectal cancer. The interventions involved in this study are: * Trifluridine (TAS-102) * Radiation Therapy
Primary Outcome
MTD will be determined using a 3 + 3 dose escalation. 3 participants enrolled at the starting dose of 20 mg/m2 BID (Bis in die, Latin for twice daily). Based on the number of dose limiting toxicities (DLT), the dose can be either be increased to 25 mg/m2 BID then 30 mg/m2 BID or it could be reduced to 15 mg/m2 BID. * If 0 out of 3 have DLT, enroll 3 participants at next dose level * If ≥ 2 DLT out of 3 or 6 participants in a dose cohort have DLT, this will be the MTD and 3 additional participan
Interventions
- DRUG TAS-102
- RADIATION Photon SBRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2025-10-02 |
| Phase | Phase 1 |
What the finished NCT03223779 record still lists
NCT03223779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which TAS-102 is the first listed.
NCT03223779 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03223779 about?
NCT03223779 is a clinical study titled "Study of TAS-102 Plus Radiation Therapy for the Treatment of the Liver in Patients With Hepatic Metastases From Colorectal Cancer". This research study is studying a drug in combination with radiation therapy as a possible treatment for hepatic metastases from colorectal cancer. The interventions involved in this study are: * Trifluridine (TAS-102) * Radiation Therapy
What is the current status of trial NCT03223779?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2017-10-13. Estimated completion is 2025-10-02.
What interventions are being tested in trial NCT03223779?
The interventions under investigation include: TAS-102 (DRUG), Photon SBRT (RADIATION).
Who is sponsoring clinical trial NCT03223779?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03223779's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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