Status:
COMPLETED
Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor
Lead Sponsor:
NYU Langone Health
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 tum...
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 evaluat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2017
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT01000662
Start Date
March 1 2009
End Date
June 14 2017
Last Update
August 6 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Bellevue Hospital Center
New York, New York, United States, 10016
2
NYU Clinical Cancer Center
New York, New York, United States, 10016
3
Tisch Hospital
New York, New York, United States, 10016