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

NYU Langone Health

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: Weekly Radiation Therapy; Radiation: Daily Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01000662

09-0030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 412 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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412 participants in 2 patient groups

ARM 1 daily boost

Active Comparator group

Description:

Radiation Therapy

Treatment:

Radiation: Daily Radiation Therapy

ARM 2 weekly boost

Active Comparator group

Description:

Radiation Therapy

Treatment:

Radiation: Weekly Radiation Therapy