Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
Sponsor: Weill Medical College of Cornell University
ClinicalTrials ID:NCT02917421
This trial involves two cohorts of breast cancer patients post-chemotherapy and surgery. Cohort 1 receives radiation to the breast/chest wall, while Cohort 2 also targets nodal areas. Treatment spans 3 weeks with 15 fractions. Eligible participants are women over 18 with Stage I-III cancer, post-surgery with negative margins. Radiation is delivered via 3D-CRT or IMRT, with specific protocols for reconstructed patients.
Patient Parameters
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Program Overview
This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
Description
Protocol has two cohorts. Cohort 1 will receive radiation to breast and chest wall. Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy x 15 fractions (40.50 Gy) with a concomitant boost of 0.50 (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Cohort 2 patients will receive radiation to breast, chest wall and LevelII/SCV nodes.
In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy).
Patients will complete treatment in three weeks (15 fractions). All patients will be followed at 3 months after the completion of treatment then yearly for the next 5 years.
Eligibility Criteria
Inclusion Criteria
- Age older than 18
- Pre- or post-menopausal women with Stage I-III breast cancer
- Status post neoadjuvant systemic therapy
- Status post-chemotherapy breast surgery
- Original biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm (patients with focally positive margin are not excluded).
- Status post segmental mastectomy or mastectomy, with either negative sentinel node biopsy and/or axillary node dissection (at least 6 nodes removed).
- 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 and/or nodal area
- Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
- Pregnant or lactating women
- Concurrent chemotherapy, with the exception of anti HER2neu therapies
- Inadequate axillary dissection in a setting of positive sentinel node
- Patients with more than 5 nodes involved at axillary dissection will be excluded from this study since they will be eligible to receive radiotherapy to level I and II axilla.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| New York Presbyterian Hospital - Queens | 10065 | New York | New York |
| Weill Cornell Medical College | 10065 | New York | New York |
| Brooklyn Methodist Hospital - NewYork Presbyterian | 11215 | New York | New York |
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