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
17 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
Researchers are studying patients in the Netherlands who have breast cancer that has returned locally or regionally (LRR) and have high-risk factors. The study evaluates the outcomes of postoperative re-irradiation treatment with or without added hyperthermia, a treatment that uses heat to potentially enhance radiation effects. There is currently no prospective data comparing these approaches, so this study aims to collect real-world information on cancer control, side effects, and quality of life to improve future treatment decisions. Patients receive standard care with postoperative re-irradiation either combined with hyperthermia treatment or without it. Hyperthermia treatment practices vary between centers, and the study seeks to harmonize these methods. The study groups include patients receiving re-irradiation plus hyperthermia and those receiving re-irradiation alone. Questionnaires about side effects and quality of life are completed at multiple times before and after treatment, including up to five years following surgery. Participants will be asked to fill out patient-reported outcome measures and toxicity questionnaires at specified intervals: one week before treatment, one week before re-irradiation, one week and three months after re-irradiation, and one, two, and five years after surgery. Researchers will track patient-reported toxicity over five years as the primary outcome, along with quality of life, survival rates, and disease recurrence at two and five years. Data on referral patterns and other outcomes will also be collected to help inform future clinical trials and treatment decisions.
CONDITIONS
Brief 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 42
- Age 18 years or older
- Patients with locoregional recurrent breast cancer after postoperative irradiation of the primary cancer, including second primary ipsilateral breast cancer
- Patients treated with salvage mastectomy with high-risk tumor characteristics or local excision with indication for postoperative re-irradiation
- Previous whole or partial breast irradiation
- (Neo)adjuvant systemic therapy allowed
- Use of (FES/FDG-)PET-CT for staging nodal and disseminated disease
- Oligometastases in certain lymph nodes allowed (up to five)
- Adequate communication and understanding of Dutch language
You will not qualify if you...
- Diagnosis of primary breast sarcoma
- Low-risk locoregional recurrence after previous breast-conserving surgery/therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies per treatment plan
Participants receive postoperative re-irradiation treatment with or without hyperthermia as part of their standard care for locoregional recurrent breast cancer.
Visit schedule depends on standard care; questionnaires for patient-reported outcomes are completed before and after re-irradiation
Duration - Up to 5 years
Participants complete questionnaires assessing toxicity, quality of life, and survival outcomes at multiple time points up to five years after surgery.
Questionnaires completed at 1 week before treatment, 1 week before re-irradiation, 1 week and 3 months after re-irradiation, and at 1, 2, and 5 years after surgery
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
L
Lisca Wurfbain, MD
D
Desiree Van Den Bongard, Dr
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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