RecruitingNot ApplicableNCT06345534

FAST-FORWARD vs HAI5

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


Sponsor

University Hospital, Ghent

Enrollment

740 participants

Start Date

May 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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).

Interventions

DEVICEQuestionnaire

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

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NCT06345534


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