Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Radiation: Daily Radiation Therapy
Radiation: Weekly Radiation Therapy

Registration Number: NCT01000662

Lead Sponsor: NYU Langone Health

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 412

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM 1 daily boost	Daily Radiation Therapy	Radiation Therapy
ARM 2 weekly boost	Weekly Radiation Therapy	Radiation Therapy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)	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 Outcome Measures

Name	Time	Method
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline	Baseline	BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment	45-60 days after treatment	SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".
Score on "SF-36 v2 Vitality" Scale	End of Treatment	SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".
Average Score on Brief Pain Inventory (BPI)	45-60 days after treatment	The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment	45-60 days after treatment	4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor."
Average Score on Brief Pain Inventory (BPI) Scale	Baseline	The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale	Baseline	4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor." The total range is 1-4; the higher the score, the lower the breast quality.
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment	At the end of Treatment, an average of 3 weeks	BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)	45-60 days after treatment	BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment	End of Treatment	4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor"

Trial Locations

Locations (3): NYU Clinical Cancer Center
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New York, New York, United States
Tisch Hospital
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New York, New York, United States
Bellevue Hospital Center
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New York, New York, United States