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

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

Plain Language Summary

Simplified for easier understanding

This study examines whether adding hyperthermia (heat therapy) to re-irradiation (a second course of radiation) improves outcomes for breast cancer patients whose cancer has come back in the chest wall or nearby lymph nodes after they previously received radiation treatment. **You may be eligible if...** - You are 18 or older with breast cancer that has returned locally (in the chest wall, skin, or nearby lymph nodes) after previous radiation treatment - You have had salvage surgery (mastectomy or local excision) with high-risk features, or need postoperative re-irradiation - You are in reasonably good health (WHO performance score 2 or below) - You can understand Dutch-language instructions **You may NOT be eligible if...** - You have primary breast sarcoma - Your recurrence is considered low-risk after previous breast-conserving surgery - You have more than 5 spread lesions in distant lymph nodes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Amsterdam UMC

Amsterdam, Netherlands

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NCT06452485


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