Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00581529|
Recruitment Status : Terminated (The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women.)
First Posted : December 27, 2007
Results First Posted : August 28, 2014
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: IMRT||Phase 2|
This is a non-randomized Phase I-II feasibility study of partial breast irradiation with accelerated IMRT technique. In this study, patients will be eligible if the estimated risk of breast cancer elsewhere in the breast (beyond the tumor bed) is low. The radiation treatment will be available to women who are older than 40 years, have a DCIS (Ductal carcinoma in situ) or T1, N0, M0, (AJCC classification, version 6.0), non-lobular infiltrating carcinoma treated with breast-conserving surgery.
Patients will undergo a pre-treatment planning free breathing CT with 5mm cuts in the treatment position, on a breast board, with both arms extended above their head that will be used to plan the traditional two field (tangent) plan. An Active Breathing Control (ABC) device will be used to minimize target motion due to breathing during a second CT scan. The lumpectomy cavity will be identified and delineated, and margins of approximately 1.5 cm in three dimensions will be used to allow for subclinical tumor extension and daily set-up error. The organs at risk (heart, lungs, contralateral breast) will be contoured on both CT scans. An inverse planning system and optimization tools will be employed in order to achieve the best IMRT plan (to minimize the dose to the heart, lungs and contralateral breast), that will be compared to the two field plan. If the IMRT plan is shown to be the optimal one, in terms of doses to organs at risk, then the patient will be enrolled in the protocol and will proceed with the treatment. Treatment will start approximately two weeks after the planning CT is obtained. All patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy in Early Stage Breast Cancer After Breast-Conserving Surgery|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||August 2014|
IMRT (Intensity-modulated Radiation Therapy), 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
- Rate of Local Control at 5 Years [ Time Frame: 5 years ]The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.
- Percentage of Participants That Experience Cosmetic Adverse Events (AEs) [ Time Frame: 5 years ]The primary outcome was to determine the rate of acute cosmetic adverse events and late cosmetic adverse events at follow-up visits over 5 years. To determine the rate of adverse events, the percentage of participants experiencing no cosmetic AEs, at least 1 grade 1 toxicity, at least 1 grade 2 toxicity, and at least 1 grade 3 toxicity were calculated.
- Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods [ Time Frame: not specific ]Dosimetric and volumetric differences between treatment plans for partial breast irradiation and other treatment planning methods for the target (partial breast) and organs at risk (e.g. heart, ipsilateral lung, contralateral breast)a subset of 20.
- Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis [ Time Frame: 5 years ]One of the studies secondary outcomes was to evaluate the impact of short term accelerated partial breast radiation therapy on cosmetic results. To determine the association between dosimetric factors and cosmesis, the mean percentage of prescription dose received to WBV (Whole breast volume: corresponding region typically encompassed by traditional tangent fields) was compared among participants who developed fair/poor (F/P) cosmetic outcomes (unacceptable cosmesis) and participants who maintained excellent/good (E/G) cosmetic outcomes (acceptable cosmesis).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581529
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-5010|
|Principal Investigator:||Lori J Pierce, MD||University of Michigan|