Postoperative Re-irradiaTion With and Without HYPERthermia: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer
NCT06452485
Summary
In the Netherlands, breast cancer patients with locoregional recurrence (LRR) and high-risk factors are treated with postoperative re-irradiation with or without hyperthermia. Retrospective studies showed that 3-year locoregional control after postoperative re-irradiation with hyperthermia was 68-83%, and severe toxicity in up to 40% of LRR patients. Unfortunately, no prospective (randomized) data are available on clinical outcomes. Consequently, variation exists in hyperthermia-treatment and re-irradiation schedules. Prospective real-world data on oncological outcomes, toxicity and quality of life is highly needed for shared decision-making between patients and professionals. These data will be used in the design of a future randomized trial comparing postoperative re-irradiation and hyperthermia-treatment in high-risk LRR patients.
Eligibility
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
Conditions5
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NCT06452485