Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - 99 |
| Updated: | 8/15/2018 |
| Start Date: | August 2016 |
| End Date: | August 2022 |
| Contact: | Sharanya Chandrasekhar, M.S. |
| Email: | shc2043@med.cornell.edu |
| Phone: | 212-746-7277 |
Accelarated Radiation Therapy (ART) to the Breast and Nodal Stations After Neo-adjuvant Chemotherapy and Surgery : A Feasibility Study.
This protocol is for patients with newly diagnosed breast cancer with an indication for
post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
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.
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.
Inclusion Criteria:
- 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
- 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
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