Breast Reconstruction and Radiotherapy

Официальное название

Breast Reconstruction and Radiotherapy: a Nationwide Cohort Study on Care Evaluation and Optimization

Обзор

If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy. However, only a few high-quality studies addressed patient satisfaction and complication risks, both in terms of timing (prior to or after irradiation) and type of reconstruction (implant or own tissue). As radiotherapy indications expand and more patients desire a reconstruction, this is a progressively relevant issue. Through this nationwide prospective study, the investigators aim to identify the most ideal treatment strategy by comparing different reconstruction options in terms of patient reported outcomes (PROs), toxicity, oncological safety and costs. These results will enable improvement of shared decision-making and cost-effectiveness of breast reconstruction strategies in case of radiotherapy.

Первичные конечные точки

• Patient satisfaction at 1 year [Срок оценки: From enrollment to one year follow-up after treatment.]
• Patient quality of life at 1 year [Срок оценки: From enrollment to one year follow-up after treatment.]

Вторичные конечные точки (7)

• Patient satisfaction at 3 and 5 years [Срок оценки: From enrollment to 3 and 5 years follow-up after treatment.]
• Patient quality of life at 3 and 5 years [Срок оценки: From enrollment to 3 and 5 years follow-up after treatment.]
• Complications prior to and following radiotherapy [Срок оценки: From enrollment to end of study follow-up (i.e. 5 years after treatment).]
• Cost-effectiveness and consumption of medical care and materials. [Срок оценки: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).]
• Time to adjuvant treatment (radiotherapy/systemic therapy). [Срок оценки: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).]
• Breast cancer recurrence rates at 3, and 5 years [Срок оценки: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).]
• Recurrence free interval, disease free survival and overall survival at 3 and 5 years. [Срок оценки: Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).]

Критерии участия

Критерии включения

• 18 years of age or older
• Diagnosed with unilateral non-metastatic breast cancer
• (to be) Treated with mastectomy and to be treated with adjuvant radiotherapy
• Willing and able to provide written informed consent

Критерии исключения

• History of DCIS or invasive breast cancer
• Previous thoracic radiotherapy treatment
• History of other malignancies (except for patients with basal or squamous cell skin cancer, in situ carcinoma of the cervix and patients who are disease-free at least 5 years following successful treatment for other malignancies)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Erasmus Medical Center — Rotterdam

Идентификаторы

NCT: NCT07178886 · 10390032310055 · 10390032310055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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