Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor
This trial is active, not recruiting.
|Sponsor||New York University School of Medicine|
|Start date||March 2009|
|End date||July 2012|
|Trial size||400 participants|
|Trial identifier||NCT01000662, 09-0030|
All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated as the daily boost during accelerated prone radiotherapy.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Acute radiation toxicities recorded according to RTOG
time frame: Day 1 of radiation treatment to day 60
QOL (Quality of Life) questionnaire of patients on the 2 different arms of treatment
time frame: at baseline, at the end of last week of treatment, and at 2 year Follow-up
Late radiation toxicities recorded according to LENT/SOMA
time frame: yearly for five years after completion of treatment
Female participants at least 18 years old.
Inclusion Criteria: - Pre or post-menopausal women with stage 0,I, and II breast cancer - Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm - Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors <5mm do not require nodal assessment) - At least 2 weeks from last chemotherapy - Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document Exclusion Criteria: - Previous radiation therapy to the ipsilateral breast - More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation - Active connective tissue disorders, such as lupus or scleroderma - Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free >3 years - Pregnant or lactating women
|Official title||Phase III Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor|
|Principal investigator||Silvia C Formenti, MD|
|Description||Arm 1 is a concomitant boost protocol over three weeks which has previously been evaluated in over 500 patients (NYU 03-30 and NYU 05-181) and has shown excellent tolerance, and results. Arm 2 evaluates a Weekend Boost Dose (WBD) regimen which may have a radiobiological advantage by counteracting tumor repopulation which can occur over the weekend break. At the time of registration in the study, patients will be randomized to either treatment arm and stratified according to pre or post-menopausal status and on previous chemotherapy received or not.|
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