Postoperative Re-irradiaTion With and Without HYPERthermia, or Surgery Only: 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 intermediate- and high-risk factors are treated with surgery with or without 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 in high-risk LRR patients.

Eligibility criteria

Qualifiers

≥ 18 years old

WHO performance scale ≤ 2

Diagnosed with local +/- regional recurrence (LRR) (i.e. true recurrence or second primary) with high-risk tumor characteristics* and previously treated with postoperative local +/- regional irradiation for primary breast cancer/previous recurrence with an indication for salvage mastectomy with/without postoperative re-irradiation (+/-hyperthermia)** if re-irradiation: including overlap of re-irradiated volume with previous irradiated volume

Diagnosed with a chest wall recurrence and treated with local excision with/without NAST and postoperative re irradiation with/without hyperthermia. In patients with a clinical/radiological complete response after neoadjuvant systemic treatment, NO surgery and re irradiation (+/- hyperthermia) (since surgery is not possible in this group)

Disqualifiers

None

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 3 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