Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

Официальное название

A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy

Обзор

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.

Вмешательства

• Лучевая терапия accelerated partial breast irradiation - 3D-conformal planning
  38.5 Gy, 10 fractions over 5 days
• Лучевая терапия accelerated partial breast irradiation - IMRT planning
  38.5 Gy, 10 fractions over 5 days

Первичные конечные точки

• Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI) [Срок оценки: 5 years]
• Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI) [Срок оценки: 2-5 years]

Вторичные конечные точки (7)

• Dosimetric comparison [Срок оценки: 5-10 days]
• Acute skin reactions [Срок оценки: 6 months]
• Cosmetic outcomes after APBI [Срок оценки: 2-5 years]
• Ipsilateral breast event [Срок оценки: 5-15 years]
• Cause specific survival [Срок оценки: 5-15 years]
• Disease free survival [Срок оценки: 5-15 years]
• Overall survival [Срок оценки: 5-15 years]

Критерии участия

Критерии включения

• Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.
• Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
• Negative surgical margins ( ≥ 0.2 cm) after final surgery.
• Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.
• Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
• Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.
• Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
• Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4.
• Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.
• PTV to ipsilateral breast ratio (IBR) ≤ 25 %.
• Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.

Критерии исключения

• Pregnancy or breast-feeding.
• Have collagen-vascular disease.
• Inadequate surgical margins ( < 0.2 cm) after final surgery.
• Subjects with persistent malignant/suspicious micro-calcifications.
• Gross multifocal disease and microscopic disease greater than 3.0 cm.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Rocky Mountain Cancer Centers - Aurora — Aurora
• Rocky Mountain Cancer Centers - Boulder — Boulder
• Rocky Mountain Cancer Centers - Lakewood — Lakewood
• Rocky Mountain Cancer Centers - Littleton — Littleton
• Rocky Mountain Cancer Centers - Thornton — Thornton

Публикации

• Leonard CE, Wang Y, Asmar L, Lei RY, Howell KT, Henkenberns PL, Johnson TK, Hobart TL, Tole SP, Kercher JM, Widner JL, Barke L, Kaske T, Carter DL. A prospective Phase III trial evaluating patient self-reported pain and cosmesis in accelerated partial breast irradiation utilizing 3-D versus intensity-modulated radiotherapy. Cancer Med. 2021 Oct;10(20):7089-7100. doi: 10.1002/cam4.4242. Epub 2021 S PMID 34469056

Идентификаторы

NCT: NCT01185132 · 2009-APBI · WIRB #20091193

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗