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NCT01581619 · ClinicalTrials.gov registry record · NA
External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
NCT01581619: Completed NA study, sponsored by Massachusetts General Hospital.
NCT01581619 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01581619, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
Study Summary
Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the "tumor bed"). The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients. The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.
Primary Outcome
The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if \>10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI. 1. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity. 2. The development of clinical fat necrosis. 3. The development of rib fracture on the ipsilateral treated side, detected either clinically and/or rad
Interventions
- RADIATION External Beam Partial-Breast Irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2012-05 |
| Est. Completion | 2019-08 |
| Phase | NA |
What the finished NCT01581619 record still lists
NCT01581619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which External Beam Partial-Breast Irradiation is the first listed.
NCT01581619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01581619 about?
NCT01581619 is a clinical study titled "External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks". Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tu...
What is the current status of trial NCT01581619?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2012-05. Estimated completion is 2019-08.
What interventions are being tested in trial NCT01581619?
The interventions under investigation include: External Beam Partial-Breast Irradiation (RADIATION).
Who is sponsoring clinical trial NCT01581619?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01581619's enrollment target sits among peer trials
54 1268th of 2000 higher than 730 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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