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临床试验/NCT06345534
NCT06345534招募中不适用

Randomized Comparison Between the FAST-FORWARD Schedule and the HAI5 Schedule for Breast Cancer Radiotherapy in 5 Fractions

University Hospital, Ghent4 个研究点 分布在 1 个国家目标入组 740 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
740
试验地点
4
主要终点
Early side effects

研究概览

简要总结

Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions.

详细描述

Previously, radiotherapy treatments for breast cancer usually consisted of 20-25 sessions to treat the entire breast, followed by an additional dose ("boost") to the tumor bed of 4-8 sessions. Today, 15-16 treatment sessions have become standard for whole breast irradiation, followed by a boost if indicated. The durability of further shortening the treatment to 5 sessions was proven in the FAST and FAST-FORWARD studies. After 10 and 5 years, the outcome was comparable with 25 and 15 radiation sessions, both in terms of toxicity and locoregional control.

There are currently 2 radiotherapy schedules in 5 sessions in use in Belgium (the FAST-FORWARD schedule and the HAI5 schedule), both of which have their advantages and disadvantages. In this project we want to investigate which schedule gives the fewest side effects and the best quality of life using questionnaires at different times (before, during and after radiation).

Patients participating in the study will be randomized 1:1 between the FAST-FORWARD schedule and the HAI5 schedule. The first group is treated according to the FAST-FORWARD schedule, consisting of 5 radiation sessions on 5 consecutive working days (e.g. Monday to Friday). In the schedule 2 rest days are allowed, so that the treatment lasts a maximum of 7 days. The second group is treated according to the HAI5 schedule, developed by the radiotherapy department of Ghent University Hospital. In this schedule, at least 1 day of rest is scheduled between each treatment session, so the treatment is administered over 10-14 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Both healthcare provider and patient know the treatment

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • histopathological diagnosis of breast cancer
  • age 18 years or older
  • male or female
  • treated with breast conserving surgery or mastectomy with curative intent
  • multidisciplinary decision of adjuvant radiotherapy after surgery

排除标准

  • distant metastases
  • decision of preoperative radiotherapy
  • decision of partial breast irradiation
  • positive resection margins ('ink on tumour')
  • indication for boost on lymph node(s)
  • history of thoracic or ipsilateral axillary radiotherapy (including radiotherapy of the contralateral breast or chest wall)
  • need for bilateral irradiation
  • breast reconstruction or expander
  • patients unlikely to comply with the protocol (e.g. inability or unwillingness to complete the questionnaires at different time points).

结局指标

主要结局

Early side effects

时间窗: Weekly up to 6 weeks after radiotherapy

To evaluate radiotherapy-related symptoms in the chest/chest wall weekly up to 6 weeks after radiotherapy, evaluated with the standardized EORTC QLQ-BR23 questionnaire.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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