Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment

Официальное название

Hypofractionated Versus Conventional Intensity-Modulated Radiation Therapy for Breast Cancer Patients With an Indication for Regional Nodal Irradiation: A Randomized Multi-center Phase III Trial

Обзор

The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.

Подробное описание

Investigators hypothesize that hypofractionated radiotherapy is equally effective and safe as conventional radiotherapy in breast cancer patients with an indication for regional nodal irradiation. Eligible breast cancer patients are randomized 1:1 into the following two groups: hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed boost of 2.67 Gy for 4 fractions in patients with intact breast) and conventional radiotherapy of 2Gy for 25 fractions (and sequential tumor bed boost of 2 Gy for 5 fractions in patients with intact breast). The dose was prescribed to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). All patients are treated with IMRT. The primary endpoint is locoregional recurrence. Patients will be followed at least 5 years after radiotherapy to evaluated over survival, distant metastasis, toxicity and life quality.

Вмешательства

• Лучевая терапия Hypofractionated radiotherapy
  4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast
• Лучевая терапия Conventional radiotherapy
  5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast

Первичные конечные точки

• Locoregional recurrence (LRR) [Срок оценки: 5 years]

Вторичные конечные точки (7)

• Distant metastasis free survival (DMFS) [Срок оценки: 5 years]
• Invasive recurrence-free survival (IRFS) [Срок оценки: 5 year]
• over survival (OS) [Срок оценки: 5 years]
• Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/NSABP/RTOG scoring scale [Срок оценки: 5 years]
• Number of Participants with ≥Grade1 Acute Radiation-induced Toxicity [Срок оценки: 6 months]
• Number of Participants with ≥Grade1 Late Radiation-induced Toxicity [Срок оценки: 5 years]
• Reconstruction complications [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age 18-75 years old
• unilateral histologically confirmed invasive breast carcinoma of pT1-3
• breast conservation surgery or mastectomy
• Breast reconstruction is allowed
• histologically confirmed positive axillary lymph nodes (positive sentinel lymph nodes without axillary dissection is allowed)
• Life expectancy of >5 years
• A minimum negative surgical margin width of >2mm
• Karnofsky Performance Status ≥80
• Estrogen-receptor, Progesterone-receptor, human epidermal growth factor receptor-2 (HER-2) and Ki67 index can be performed on the primary breast tumor or axillary nodes.
• Written informed consent

Критерии исключения

• Supraclavicular lymph nodes, positive ipsilateral internal mammary lymph nodes or residual axillary nodes that may be eligible for a boost dose.
• Pregnant or lactating
• Severe non-neoplastic medical comorbidities
• Diagnosis of non-breast malignancy within 5 years preceding enrollment (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix).
• Simultaneous contralateral breast cancer
• Previous RT to thoracic and/or axillary, cervical region
• Active collagen vascular disease
• Evidence of distant metastatic disease and/or T4 disease

Notes for exlusion criteria:

• Patients with severe non-neoplastic medical comorbidities (e.g.,severe ischemic heart disease, severe arrhythmia or severe chronic obstructive pulmonary disease ) that would preclude radiation treatment will be excluded.
• Simultaneous contralateral breast cancer includes histologically confirmed DCIS only.

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 · 1 центр

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай

Публикации

• Xie J, Xu F, Zhao Y, Cai G, Lin X, Zhu Q, Lin Q, Yao Y, Xu C, Cai R, Wang S, Tang X, Chen C, Zheng S, Chen M, Chen M, Qian X, Shen C, Li J, Xu H, Xu F, Han Y, Li M, Ou D, Shen KW, Qi WX, Cao L, Huang X, Chen J. Hypofractionated versus conventional intensity-modulated radiation irradiation (HARVEST-adjuvant): study protocol for a randomised non-inferior multicentre phase III trial. BMJ Open. 2022 S PMID 36581983

Идентификаторы

NCT: NCT03829553 · RJBC-HFRNI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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