Actively Recruiting
Postoperative Re-irradiaTion With and Without HYPERthermia: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer
Led by Amsterdam UMC, location VUmc · Updated on 2025-10-06
500
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
B
Borstkanker Onderzoek Groep
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Postoperative Re-irradiaTion With and Without HYPERthermia: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- WHO performance scale 2 or less
- Age 18 years or older
- Locoregional recurrent breast cancer after postoperative irradiation of primary breast cancer
- Locoregional recurrence includes local and/or regional recurrence or second primary ipsilateral breast cancer
- Treated with salvage mastectomy with high-risk tumor characteristics or local excision with indication for postoperative re-irradiation
- Previously treated with whole or partial breast irradiation
- (Neo)adjuvant systemic therapy is allowed
- Use of (FES/FDG-)PET-CT for staging nodal and disseminated disease
- Oligometastases in lymph nodes in mediastinum, neck, contralateral axillary/supraclavicular region allowed up to five nodes
- Adequate Dutch language communication and understanding skills
You will not qualify if you...
- Diagnosed with primary breast sarcoma
- Have low-risk locoregional recurrence after previous breast-conserving surgery/therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
L
Lisca Wurfbain, MD
CONTACT
D
Desiree Van Den Bongard, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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