RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Официальное название

RAD 1802: A Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Обзор

This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

Подробное описание

This study offers 5 fractions stereotactic body radiotherapy for early stage breast cancer after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility of delivering only 5 doses of radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.

Вмешательства

• Лучевая терапия 5 Fraction Stereotactic Body Radiation Therapy
  Stereotactic body radiation therapy (SBRT) has gained favor in the treatment of select central nervous system, lung, and abdominal malignancies due to its ability to deliver highly conformal doses of radiotherapy while using sharp dose gradients to deliver comparatively lower doses to the surrounding normal tissue. Utilization of SBRT is more labor intensive than conventional fractionation and requires precise immobilization and localization techniques with daily image guidance with direct physi

Первичные конечные точки

• Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0 [Срок оценки: 0-2 years]

Вторичные конечные точки (3)

• Toxicity of breast SBRT using CTCAE v4.0 [Срок оценки: 0-2 years]
• Cosmetic outcome baseline and post-SBRT [Срок оценки: 0-2 years]
• Patient reported outcome baseline and post-SBRT [Срок оценки: 0-2 years]

Критерии участия

Критерии включения

• Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed.
• Age>50.
• Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS.
• Estrogen receptor (ER) positive (>10%).
• Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm.
• Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative.
• Zubrod Performance Status 0-2.

Критерии исключения

• Multifocal or multicentric cancer.
• Reception of neoadjuvant chemotherapy.
• Pure invasive lobular histology.
• Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
• Measured maximum PTV of >124cc.
• Lumpectomy cavity within 5mm of body contour.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC — Birmingham

Публикации

• Liu Y, Veale C, Hablitz D, Krontiras H, Dalton A, Meyers K, Dobelbower M, Lancaster R, Bredel M, Parker C, Keene K, Thomas E, Boggs D. Feasibility and Short-Term Toxicity of a Consecutively Delivered Five Fraction Stereotactic Body Radiation Therapy Regimen in Early-Stage Breast Cancer Patients Receiving Partial Breast Irradiation. Front Oncol. 2022 Jul 8;12:901312. doi: 10.3389/fonc.2022.901312. PMID 35880164

Идентификаторы

NCT: NCT03643861 · IRB-300002157 · 000521633

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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