Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- NYU Langone Health
- Enrollment
- 412
- Locations
- 3
- Primary Endpoint
- Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)
Time Frame: Day 60
Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects
Secondary Outcomes
- Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline(Baseline)
- Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment(45-60 days after treatment)
- Score on "SF-36 v2 Vitality" Scale(End of Treatment)
- Average Score on Brief Pain Inventory (BPI)(45-60 days after treatment)
- Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment(45-60 days after treatment)
- Average Score on Brief Pain Inventory (BPI) Scale(Baseline)
- Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale(Baseline)
- Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment(At the end of Treatment, an average of 3 weeks)
- Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)(45-60 days after treatment)
- Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment(End of Treatment)