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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Lisca Wurfbain, MD
l.f.wurfbain@amsterdamumc.nl
+31 6-25414750
Backup
Desiree Van Den Bongard, Dr
h.j.vandenbongard@amsterdamumc.nl
+31 6-25414750
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-05
Participants
Target number of participants: 500
Treatments
Postoperative re-irradiation with hyperthermia
Postoperative re-irradiation with hyperthermia in patients with locoregional recurrent breast cancer
Postoperative re-irradiation without hyperthermia
Postoperative re-irradiation without hyperthermia in patients with locoregional recurrent breast cancer
Related Therapeutic Areas
Sponsors
Collaborators: Borstkanker Onderzoek Groep, Comprehensive Cancer Centre The Netherlands, Dutch Cancer Society
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov

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