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

RECRUITINGSponsored by Amsterdam UMC, location VUmc
Actively Recruiting
SponsorAmsterdam UMC, location VUmc
Started2024-01-01
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Breast CancerCancerHyperthermiaLocoregional RecurrenceRe-irradiation

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