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NCT01591811 · ClinicalTrials.gov registry record · Phase 3
Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost
A Phase 3 study of Breast Cancer, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 433
- Enrollment target
- 1
- Study location
NCT01591811 is a Phase 3 study of Breast Cancer that has completed, run by NYU Langone Health. The registered enrollment target is 433 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01591811, a Phase 3 study of Breast Cancer, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 433 participants
- Enrollment target
- 1
- Study location
Study Summary
1. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy and randomly assigned to either a weekly or a daily boost to the tumor bed develop acute toxicity that is not significantly worse than that of a concurrent cohort of patients treated with IMRT randomly assigned to a weekly or daily boost regimen. 2. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy, randomly assigned to either a weekly or a daily boost to the tumor bed develop late toxicity that is not significantly worse than that of concurrent cohort of patients treated with IMRT randomly assigned to a weekly of daily boost. 3. To test hypothesis that 5 year local control rates of ≤ 5% in-breast recurrence can be achieved in each of the two randomized arms, for either technique tested.
Conditions Studied
Interventions
- RADIATION Arm 1 Daily Boost of Radiation Therapy
- RADIATION Arm 2 Weekly Boost of Radiation Therapy
Study Locations (1)
New York
- NYU Cancer Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2012-04-16 |
| Est. Completion | 2015-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01591811
The ClinicalTrials.gov registry entry for NCT01591811 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 433 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (85% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Arm 1 Daily Boost of Radiation Therapy is the first listed.
NCT01591811 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01591811 about?
NCT01591811 is a clinical study titled "Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost". 1. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy and randomly assigned to either a weekly or a daily boost to the tumor bed develop acute toxicity that is not significantly worse than that of a concurrent cohort of patients treated with IMRT randomly assign...
What is the current status of trial NCT01591811?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 433 participants. The study started on 2012-04-16. Estimated completion is 2015-04-30.
What conditions does trial NCT01591811 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01591811?
The interventions under investigation include: Arm 1 Daily Boost of Radiation Therapy (RADIATION), Arm 2 Weekly Boost of Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01591811?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01591811 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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