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Postoperative Re-irradiaTion With and Without HYPERthermia: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer
Sponsor: Amsterdam UMC, location VUmc
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2024-01-01
Completion Date
2027-05
Last Updated
2025-10-06
Healthy Volunteers
No
Interventions
No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups.
Patients will receive standard of care. Patients need to fill in questionnaires, these are additional interventions for the included subject. Questionnaires for patient-reported outcomes (PROMs) and toxicity will be filled in one week before treatment, one week before re-irradiation, one week and three months after re-irradiation, one, two and five years after surgery.
Locations (1)
Amsterdam UMC
Amsterdam, Netherlands