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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: Completed Phase 3 study of Breast Cancer, sponsored by NYU Langone Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
By accruing 1000 patients randomized in strata defined by the two approaches to either weekly or daily boost, we will be able to establish the feasibility using different techniques and toxicity of prone breast radiotherapy with a weekly versus a daily boost, with IMRT and with 3DCRT non-IMRT approaches.
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 |
What the finished NCT01591811 record still lists
NCT01591811 is an interventional study that assigns participants to a tested intervention. The registered 433 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01591811's enrollment target sits among peer trials
433 221st of 1224 higher than 1,004 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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