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NCT02086578 · ClinicalTrials.gov registry record · Phase 2
Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions
A Phase 2 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 7
- Study locations
NCT02086578: Completed Phase 2 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02086578 is a Phase 2 study of Breast Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 100 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02086578, a Phase 2 study of Breast Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to determine if a radiation treatment called "Multi-beam Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant if they are a candidate for radiation therapy. Currently, the standard method of giving radiation is with "3D radiation", which only uses 2-5 beams of radiation. "Multi-beam" IMRT works by using 8-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is to reduce complications after irradiation to the implants. The study doctors have recently completed a trial using this technique and are now specifically looking at its impact on women with implant reconstructions who are undergoing post-mastectomy radiation therapy. By delivering a more "customized" dose of radiation to the implant, the intent is to reduce side effects of radiation on the implant.
Primary Outcome
The multi-beam IMRT would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2).
Conditions Studied
Interventions
- DEVICE Breast MRI
- BEHAVIORAL Breast-Q© questionnaire
- RADIATION Multi-Beam IMRT
Study Locations (7)
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering at Mercy Medical Center - Rockville Centre
- Memorial Sloan Kettering Nassau (Follow-Up only) - Uniondale
New Jersey
- Memorial Sloan Kettering at Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-03-11 |
| Est. Completion | 2024-09-13 |
| Phase | Phase 2 |
What the finished NCT02086578 record still lists
NCT02086578 is an interventional study that assigns participants to a tested intervention. The registered 100 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 (96% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Breast MRI is the first listed.
NCT02086578 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT02086578 about?
NCT02086578 is a clinical study titled "Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions". The purpose of this study is to determine if a radiation treatment called "Multi-beam Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant if they are a candidate for radiation therapy. Currently, the standard method of giving radiation is with "3D radiation",...
What is the current status of trial NCT02086578?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2014-03-11. Estimated completion is 2024-09-13.
What conditions does trial NCT02086578 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02086578?
The interventions under investigation include: Breast MRI (DEVICE), Breast-Q© questionnaire (BEHAVIORAL), Multi-Beam IMRT (RADIATION).
Who is sponsoring clinical trial NCT02086578?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02086578 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02086578's enrollment target sits among peer trials
100 565th of 1224 higher than 630 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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