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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2017-06-14

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ARM 1 daily boost

Radiation Therapy

Group Type ACTIVE_COMPARATOR

Daily Radiation Therapy

Intervention Type RADIATION

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 weekly boost

Radiation Therapy

Group Type ACTIVE_COMPARATOR

Weekly Radiation Therapy

Intervention Type RADIATION

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.

Interventions

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Daily 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.

Intervention Type RADIATION

Weekly 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.

Intervention Type RADIATION

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No