Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years

Launched by UNIVERSITY HOSPITAL, GHENT · Apr 14, 2017

Keywords

ClinConnect Summary

This clinical trial is studying two different ways of giving radiation therapy to women over 65 years old who have early or locally advanced breast cancer. The researchers want to find out if giving radiation in 5 sessions over 10 days is as effective and safe as giving it in 15 sessions over 3 weeks. They will look at long-term effects like changes in the shape of the breast, as well as short-term side effects, how well the treatment controls the cancer, and how satisfied patients are with the results.

To participate in this study, women must have had surgery for breast cancer and be recommended for radiation therapy. They should not have any other serious health issues that would complicate the treatment or its effects. Participants will receive the assigned radiation therapy and will be monitored closely for any side effects. It's important for potential participants to understand the study and be willing to follow all the required steps, including returning for follow-up visits.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • breast conserving surgery or mastectomy for breast carcinoma
• • multidisciplinary decision of adjuvant irradiation
• • absence of distant metastases
• • informed consent obtained, signed and dated before specific protocol procedures
• Exclusion Criteria:
• • History of previous radiation treatment to the same region
• • Bilateral breast irradiation
• • Life expectancy of less than 2 years
• • Planned reconstructive breast surgery
• • Condition making toxicity evaluation difficult, e.g. skin disorders, pre-existing brachial plexus injury, ...
• • Inability to respect constraints on skin, heart, lungs, esophagus, ribs, brachial plexus or any other organ at risk
• • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
• • Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits or unlikely to complete the study