Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery

Официальное название

Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial

Обзор

The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery

Подробное описание

Eligible patients after breast conserving surgery will be randomized 1:1 into hypofractionated radiotherapy (HF-RT) group or conventionally fractionated radiotherapy (CF-RT) group.

Patients in HF-RT group will receive 40 Gy/15 fractions irradiation to the whole breast with/without regional lymphnodes within 3 weeks and the tumor bed is boosted to 48 Gy/15 fractions simutaneously.

Patients in CF-RT group will receive 50 Gy/ 25 fractions irradiation to whole breast with/without regional lymphnodes within 5 weeks and the tumor bed is boosted to 60 Gy/30 fractions sequentially.

The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.

It is hypothesized that hypofractionated radiotherapy is non inferior to conventional fractionated radiotherapy in terms of tumor loco-regional control for patients after breast conserving surgery.

Вмешательства

• Лучевая терапия Hypofractionated Radiotherapy
  daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
• Лучевая терапия Conventional fractionated Radiotherapy
  daily fractions, 2 Gy per fraction, five fractions per week

Первичные конечные точки

• Loco-regional recurrence (LRR) [Срок оценки: 5 years]

Вторичные конечные точки (10)

• Distant metastasis free survival (DMFS) [Срок оценки: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years]
• Disease free survival (DFS) [Срок оценки: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years]
• Overall survival (OS) [Срок оценки: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years]
• Number of patients with radiation-induced acute toxicity assesses by CTCAE4.03 [Срок оценки: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation, 2 weeks and 3 months after the irradiation finished]
• Number of patients with radiation-induced late toxicity assesses by CTCAE4.03 [Срок оценки: before treatment, every year after the last fraction received through 10 years]
• Number of patients with radiation-induced late toxicity assesses by LENT-SOMA Toxicity Assessment [Срок оценки: before treatment, every year after the last fraction received through 10 years]
• Harvard/NSABP/RTOG Breast Cosmesis Grades of patients [Срок оценки: before treatment, every year after the last fraction received through 10 years]
• Quality of Life Score assessed by EORTC-QLQ-C30 (version 3) [Срок оценки: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation，every year after the treatment finished through 10 years]
• Quality of Life Score assessed by EORTC breast-cancer module (BR23) [Срок оценки: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation, every year after the last fraction received through 10 years]
• Number and percentage of peripheral blood lymphocytes [Срок оценки: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation]

Критерии участия

Критерии включения

• Female
• Age18-70 years
• Imaging examination confirmed single lesion. if the tumor is multiple, it needs to be removed by single quadrantectomy
• Receive breast conserving surgery with negative margins
• Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillary lymph node dissection. If the sentinel lymph node is negative, the axillary lymph node dissection can be omitted. If it is positive, level I/II axillary lymph node dissection with or more than 10 lymph nodes is needed.
• The tumor bed is labeled with clips and it can be drawn on the treatment planning system.
• Pathologically confirmed invasive breast cancer
• Pathologically stage is T1-3N0-3M0
• Immunohistochemical examination is conducted to determine the status of ER, PR, HER2, Ki67 after surgery
• No distant metastases
• No supraclavicular or internal mammary nodes metastases
• No neoadjuvant chemotherapy
• Fit for postoperative radiotherapy. No contraindications to radiotherapy
• KPS≥80
• Signed informed consent

Критерии исключения

• T4 or M1 breast cancer
• Supraclavicular or internal mammary nodes metastases
• Pathologically confirmed DCIS only without an invasive component
• Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
• Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy
• Multiple lesions can not be removed by single quadrantectomy
• Suspicious unresected and microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast)
• KPS ≤ 70
• Patients with severe non-malignant comorbidity in cardiovascular or respiration system
• Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
• Previous radiotherapy to the chest wall or regional lymph node areas
• Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
• Pregnant or lactating
• Conditions indicating that the patient cannot go through the radiation therapy or follow up
• Unable or unwilling to sign informed consent

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

Китай · 5 центров

• Guizhou Provincial People's Hospital — Guiyang
• Suzhou Municipal hospital — Сучжоу
• The Second Hospital of Dalian Medical University — Dalian
• Shanghai Huangpu District Central Hospital — Шанхай
• Fudan University Shanghai Cancer Center — Шанхай

Публикации

• Jin K, Luo J, Yu X, Guo X. Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial. Radiat Oncol. 2024 May 27;19(1):62. doi: 10.1186/s13014-024-02449-y. PMID 38802888

Идентификаторы

NCT: NCT04025164 · FDRT-BC007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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