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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Daily Radiation Therapy
* Radiation: Weekly Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARM 1 daily boost<br>Radiation Therapy | Radiation: Daily Radiation Therapy<br>* 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.<br>|
| Active Comparator: ARM 2 weekly boost<br>Radiation Therapy | Radiation: Weekly Radiation Therapy<br>* 15 weekly 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG) | 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 | Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at 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. | Baseline | 
| Score on SF-36 v2 Vitality Scale | 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. | Baseline | 
| Average Score on Brief Pain Inventory (BPI) Scale | 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. | Baseline | 
| Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale | 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. | Baseline | 
| Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of 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. | At the end of Treatment, an average of 3 weeks | 
| Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) | 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. | 45-60 days after treatment | 
| Score on SF-36 v2 Vitality Scale | 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. | End of Treatment | 
| Score on SF-36 v2 Vitality Scale 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. | 45-60 days after treatment | 
| Average Score on Brief Pain Inventory (BPI) | 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. | At the end of Treatment, an average of 3 weeks | 
| Average Score on Brief Pain Inventory (BPI) | 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. | 45-60 days after treatment | 
| Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment | 4 levels: 1 = Excellent; 2 = Good; 3 = Fair; 4 = Poor | End of Treatment | 
| Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment | 4 levels: 1 = Excellent; 2 = Good; 3 = Fair; 4 = Poor. | 45-60 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whole breast radiotherapy, tumor bed boost