FAST-FORWARD vs HAI5
ConditionCancer, Breast
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent
About this trial
Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
histopathological diagnosis of breast cancer
age 18 years or older
male or female
treated with breast conserving surgery or mastectomy with curative intent
Disqualifiers
distant metastases
decision of preoperative radiotherapy
decision of partial breast irradiation
positive resection margins ('ink on tumour')
Trial design
Design model
Parallel
Treatments tested in this trial
Questionnaire
DevicePatients 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.
Treatment groups
740 Participants
are divided into 2 treatment groupsGroup A: FAST-FORWARD scheduleOther 1 intervention
Group B: HAI5 scheduleOther 1 intervention
Trial outcomes
Primary outcomes
1
Early side effects
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.
Time frame
Weekly up to 6 weeks after radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov