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Active (not recruiting) Phase 1/2 NCT02917421

Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations

Phase 1/2 – combined early trial
Conditions: Breast Cancer

Sponsor: Weill Medical College of Cornell University

trial.available_in: БГ
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.
Who can participate
The study will also include patients who because of COVID had undergone up to 3 months neoadjuvant hormonal therapy before surgery for clinical T1/T2 BC. 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.
Interventions
Radiation
RADIATION
Locations 3
United States (3)
New York Presbyterian Hospital - Queens
New York , New York
Weill Cornell Medical College
New York , New York
Brooklyn Methodist Hospital - NewYork Presbyterian
New York , New York
Technical details
Status
Active (not recruiting)
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
19 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
19.12.2016
Completion date
31.12.2026
Registry ID
NCT02917421
Source
clinicaltrials.gov
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