Postoperative Re-irradiaTion With and Without HYPERthermia: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer

Launched by AMSTERDAM UMC, LOCATION VUMC · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a treatment called re-irradiation, both with and without adding a procedure called hyperthermia, for patients who have breast cancer that has returned in the same area after previous treatment. The goal is to understand how these treatments affect patients' survival, quality of life, and any side effects they may experience. By collecting this information, researchers aim to help doctors and patients make better decisions about treatment options in the future.

To be eligible for this trial, participants must be at least 18 years old and have a specific type of breast cancer recurrence that followed earlier radiation treatment. They should also be able to communicate in Dutch and meet certain health criteria. If you decide to join, you can expect to receive careful monitoring and support throughout the study. This trial is currently recruiting participants, and your involvement could contribute valuable information that may improve treatment for future breast cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • WHO performance scale ≤2
• • \>=18 years
• • Patients with a LRR breast cancer after postoperative irradiation of the primary breast cancer. LRR is defined as a local and/or regional recurrence, including patients with a second primary ipsilateral breast cancer.
• • Patients treated with salvage mastectomy with high-risk\* tumor characteristics or local excision with an indication for postoperative re-irradiation.
• • Previously treated with whole or partial breast irradiation.
• • (Neo)adjuvant systemic therapy (NST) is allowed.
• • Use of (FES/FDG-)PET-CT in staging of nodal and disseminated disease.
• • Oligometastases in lymph nodes in the mediastinum, neck, contralateral axillary/supraclavicular region (up to a maximal number of five) is allowed.
• • Adequate communication and understanding skills of the Dutch language.
• Exclusion Criteria:
• • Diagnosed with primary breast sarcoma
• • Have a low-risk LRR after previous breast-conserving surgery/therapy