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Активно (без набиране) Фаза 1/2 NCT02917421

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

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Breast Cancer

Спонсор: Weill Medical College of Cornell University

Налично на: БГ
Обобщение
This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
Описание
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.
Кой може да участва
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.
Интервенции
Radiation
RADIATION
Места на провеждане 3
САЩ (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
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
19 Years
Максимална възраст
99 Years
Здрави доброволци
Не
Начална дата
19.12.2016
Крайна дата
31.12.2026
Регистрационен номер
NCT02917421
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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