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RECRUITINGINTERVENTIONAL

FAST-FORWARD vs HAI5

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DEVICE

Questionnaire

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.

Locations (2)

Universitary Hospital
Ghent, Belgium
University Hospital Ghent
Ghent, Belgium