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NCT02755896 · ClinicalTrials.gov registry record · Phase 2
Trial to Compare Radiation Fibrosis With Five Versus Three Fractions
A Phase 2 study of Malignant Neoplasm of Breast Stage I, sponsored by Weill Medical College of Cornell University.
- Active
- Registry status
- Phase 2
- Development phase
- 350
- Enrollment target
- 4
- Study locations
NCT02755896: Active Phase 2 study of Malignant Neoplasm of Breast Stage I, sponsored by Weill Medical College of Cornell University.
NCT02755896 is a Phase 2 study of Malignant Neoplasm of Breast Stage I that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 350 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (163% higher). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02755896, a Phase 2 study of Malignant Neoplasm of Breast Stage I, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 350 participants
- Enrollment target
- 4
- Study locations
Study Summary
Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.
Primary Outcome
The primary analysis will be the difference in proportions of patients with grade 2 or 3 fibrosis between the two treatment groups compared using a non-inferiority z- test. The proportions of patients by grade of fibrosis will be compared in the two treatment arms using contingency table methods and chi square tests.
Conditions Studied
Interventions
- RADIATION Arm 1 600 cGY x 5 fractions
- RADIATION Arm 2 800 cGY x 3 fractions
Study Locations (4)
New York
- Weill Cornell Medical College - New York
- Brooklyn Methodist Hospital - NewYork Presbyterian - New York
- New York Presbyterian Hospital - Queens - New York
California
- University of Southern California - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2015-10-14 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What the registry record for NCT02755896 still lists
NCT02755896 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (163% higher).
The record links to 1 condition, with Malignant Neoplasm of Breast Stage I appearing as the primary indexed condition, and to 2 interventions - of which Arm 1 600 cGY x 5 fractions is the first listed.
NCT02755896 reports a single indexed study location in New York, California.
Frequently Asked Questions
What is clinical trial NCT02755896 about?
NCT02755896 is a clinical study titled "Trial to Compare Radiation Fibrosis With Five Versus Three Fractions". Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the comp...
What is the current status of trial NCT02755896?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2015-10-14. Estimated completion is 2027-12.
What conditions does trial NCT02755896 study?
This clinical trial studies the following conditions: Malignant Neoplasm of Breast Stage I.
What interventions are being tested in trial NCT02755896?
The interventions under investigation include: Arm 1 600 cGY x 5 fractions (RADIATION), Arm 2 800 cGY x 3 fractions (RADIATION).
Who is sponsoring clinical trial NCT02755896?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02755896 being conducted?
This trial has 4 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02755896's enrollment target sits among peer trials
350 130th of 2000 higher than 1,865 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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