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NCT03051464 · ClinicalTrials.gov registry record · Phase 2
No Surgery Trial / Two Dose-escalation Strategies
A Phase 2 study of Stage II Rectal Cancer, sponsored by Sir Mortimer B. Davis - Jewish General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
- 4
- Study locations
NCT03051464 is a Phase 2 study of Stage II Rectal Cancer that is actively recruiting participants, run by Sir Mortimer B. Davis - Jewish General Hospital. The registered enrollment target is 131 participants. The trial reports 4 study locations across 2 states.
The verdict
NCT03051464, a Phase 2 study of Stage II Rectal Cancer, is actively recruiting participants, sponsored by Sir Mortimer B. Davis - Jewish General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
- 4
- Study locations
Study Summary
A randomized study of 131 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).
Conditions Studied
Interventions
- PROCEDURE Complete responders and Non-complete responders
- RADIATION Chemoradiation + EBRT Boost
- RADIATION Chemoradiation + HDRBT Boost
Study Locations (4)
Quebec
- Le Centre Hospitalier de l'Université de Montreal - Montreal
- Jewish General Hospital - Montreal
- Centre hospitalier universitaire de Québec - Québec
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2017-04-25 |
| Est. Completion | 2030-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03051464
The ClinicalTrials.gov registry entry for NCT03051464 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sir Mortimer B. Davis - Jewish General Hospital, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stage II Rectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Complete responders and Non-complete responders is the first listed.
NCT03051464 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Quebec, Texas.
Frequently Asked Questions
What is clinical trial NCT03051464 about?
NCT03051464 is a clinical study titled "No Surgery Trial / Two Dose-escalation Strategies". A randomized study of 131 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with...
What is the current status of trial NCT03051464?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2017-04-25. Estimated completion is 2030-01.
What conditions does trial NCT03051464 study?
This clinical trial studies the following conditions: Stage II Rectal Cancer.
What interventions are being tested in trial NCT03051464?
The interventions under investigation include: Complete responders and Non-complete responders (PROCEDURE), Chemoradiation + EBRT Boost (RADIATION), Chemoradiation + HDRBT Boost (RADIATION).
Who is sponsoring clinical trial NCT03051464?
This trial is sponsored by Sir Mortimer B. Davis - Jewish General Hospital, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03051464 being conducted?
This trial has 4 study locations across Texas, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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