Comparing two radiotherapy schedules for breast cancer treatment
Randomized Comparison Between the FAST-FORWARD Schedule and the HAI5 Schedule for Breast Cancer Radiotherapy in 5 Fractions
This study is testing two different schedules of radiotherapy for breast cancer to see which one causes fewer side effects and helps patients feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 740 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Ghent and 1 other locations) |
| Trial ID | NCT06345534 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the FAST-FORWARD and HAI5 radiotherapy schedules for breast cancer, both of which consist of 5 treatment sessions. Participants will be randomly assigned to one of the two schedules to evaluate which one results in fewer side effects and better quality of life. The study will utilize questionnaires administered at various time points before, during, and after the treatment to gather data on patient experiences and outcomes. The trial builds on previous findings that shorter treatment regimens can be as effective as longer ones in terms of toxicity and cancer control.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histopathological diagnosis of breast cancer who have undergone surgery with curative intent.
Not a fit: Patients with distant metastases or those requiring preoperative or partial breast irradiation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and patient-friendly radiotherapy schedule for breast cancer treatment.
How similar studies have performed: Previous studies have shown that shorter radiotherapy schedules can be effective, making this approach promising yet still requiring further investigation.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Ghent and 1 other locations
- Universitary Hospital — Ghent, Belgium (Not_yet_recruiting)
- University Hospital Ghent — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Liv Veldeman, MD, PhD — UZ Ghent
- Study coordinator: Liv Veldeman, MD, PhD
- Email: liv.veldeman@uzgent.be
- Phone: 09 332 30 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.