RecruitingNCT06452485

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

Enrollment

500 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Locoregional Recurrence Re-irradiation Hyperthermia

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria2

Diagnosed with primary breast sarcoma
Have a low-risk LRR after previous breast-conserving surgery/therapy

Interventions

OTHERNo 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.