Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

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.

Daily Radiation Therapy

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.

Weekly Radiation Therapy

Carmen Perez, MD

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.

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.

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

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

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

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.

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".

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.

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.

4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor"

4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor."

NYU Langone Health

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.

ARM 1 Daily Boost

ARM 2 Weekly Boost

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Silvia Formenti, Chairman, Department of Radiation Oncology

Patients receiving either daily or weekly boost to radiation therapy

Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)

Functional Status

Cosmetic Status

Breast Specific Pain

Radiation Therapy

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.

Radiation Therapy

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor	NCT01000662	Breast Cancer	Daily Radiation... Weekly Radiatio...	18 Years -	NYU Langone Health
Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor	NCT01000662	Breast Cancer	Daily Radiation... Weekly Radiatio...	18 Years -	NYU Langone Health

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