Ultra-hypofractionated radiotherapy for early stage breast cancer
Ultra-hypofractionated Adjuvant Radiotherapy After Breast Conserving Surgery in Breast Cancer Patients
This study is testing a new way of giving radiation therapy to women with early stage breast cancer after surgery to see if it is safe and effective in helping them live better and longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University Of Perugia Academic / other |
| Locations | 1 site (Perugia) |
| Trial ID | NCT05586256 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study evaluates the effectiveness and safety of an ultra-hypofractionated whole breast irradiation schedule (26 Gy in 5 fractions) for women with early stage breast cancer who have undergone breast conserving surgery. The study aims to confirm findings from previous literature, particularly the FAST-Forward trial, in a real-world clinical setting. Participants will be assessed for acute and chronic toxicity, overall survival, disease-free survival, and quality of life, among other outcomes. The study allows for various radiotherapy techniques and includes both retrospective and prospective data collection.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with early stage breast cancer who have undergone breast conserving surgery and do not require regional nodal irradiation.
Not a fit: Patients who have undergone mastectomy or require regional nodal irradiation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less toxic radiotherapy option for early stage breast cancer patients.
How similar studies have performed: Previous studies, such as the FAST-Forward trial, have shown success with similar ultra-hypofractionated approaches in breast cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients * Age ≥ 18 years. * Early stage breast cancer treated with breast conserving surgery * Whole breast irradiation without regional nodal irradiation * Infiltrating carcinomas * CDIS * Written informed consent Exclusion Criteria: * Age\<18 years. * Regional nodal radiotherapy. * Distant metastases. * Previous history of malignancy except basaloid skin tumours and CIN. Previous history of breast cancer is not an exclusion criteria if treated with curative intent and if patient is disease free at least 5 years from diagnosis. * Presence of absolute radiotherapy contraindications (pregnancy, inability to maintain the correct treatment position) and relative radiotherapy contraindications (connective tissue diseases including rheumatoid arthritis, scleroderma, systemic lupus erythematosus, dermatomyositis and vasculitis, especially if the disease is in an active phase) * Patient's refusal to use data for research purposes.
Where this trial is running
Perugia
- Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia — Perugia, Italy (Recruiting)
Study contacts
- Principal investigator: Cynthia Aristei, MD — Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia
- Study coordinator: Cynthia Aristei, MD
- Email: cynthia.aristei@unipg.it
- Phone: +390755783254
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.