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Trial Title:
FAST-FORWARD vs HAI5
NCT ID:
NCT06345534
Condition:
Cancer, Breast
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Masking description:
Both healthcare provider and patient know the treatment
Intervention:
Intervention type:
Device
Intervention name:
Questionnaire
Description:
Patients will be asked to complete questionnaires at different times (before, during and
after radiation) to evaluate which schedule gives the fewest side effects and the best
quality of life.
The basic questionnaire and questionnaire about early side effects will be completed
weekly up to 6 weeks after radiotherapy. The questionnaire about late side effects will
be completed: after 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Arm group label:
FAST-FORWARD schedule
Arm group label:
HAI5 schedule
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitary Hospital
Address:
City:
Ghent
Zip:
9000
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Liv Veldeman, MD, PhD
Phone:
09 332 30 15
Email:
liv.veldeman@uzgent.be
Contact backup:
Last name:
Emma Van Damme
Phone:
09 332 19 53
Email:
emma.vandamme@uzgent.be
Facility:
Name:
University Hospital Ghent
Address:
City:
Ghent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Emma Van Damme
Email:
Emma.VanDamme@uzgent.be
Investigator:
Last name:
Liv Veldeman, Prof. dr.
Email:
Principal Investigator
Start date:
May 30, 2024
Completion date:
December 31, 2033
Lead sponsor:
Agency:
University Hospital, Ghent
Agency class:
Other
Source:
University Hospital, Ghent
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06345534
