Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment radiation therapy
Phase phase 3
Sponsor New York University School of Medicine
Start date March 2009
End date July 2012
Trial size 400 participants
Trial identifier NCT01000662, 09-0030

Summary

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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Radiation Therapy
radiation therapy
Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed. Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
(Active Comparator)
Radiation Therapy
radiation therapy
Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed. Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.

Primary Outcomes

Measure
Acute radiation toxicities recorded according to RTOG
time frame: Day 1 of radiation treatment to day 60

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by New York University School of Medicine.