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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Diagnosed with primary breast sarcoma

Have a low-risk LRR after previous breast-conserving surgery/therapy

Trial design

Treatments tested in this trial

  • No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups.

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Amsterdam UMC, location VUmc

Lead sponsor

Borstkanker Onderzoek Groep

Collaborator

Comprehensive Cancer Centre The Netherlands

Collaborator

Dutch Cancer Society

Collaborator