Clinical trial NCT06345534: FAST-FORWARD vs HAI5
Official title: Randomized Comparison Between the FAST-FORWARD Schedule and the HAI5 Schedule for Breast Cancer Radiotherapy in 5 Fractions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Breast
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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). 2 rest days are allowed in the schedule, 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.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Early side effects
timeFrame: Weekly up to 6 weeks after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Universitary Hospital
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: UZ Ghent
name: Liv Veldeman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: