Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction

Официальное название

Comparison of Patient-Reported Outcome and Safety Outcomes Between Preoperative and Postmastectomy Radiotherapy in Breast Cancer Patients with Reconstruction of DIEP Flap: a Multicenter，Prospective，Open-label，Randomized Controlled Trial

Обзор

This study is the first prospective randomized study assessing the patient-reported outcomes and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction of deep inferior epigastric perforator(DIEP) flap. Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. We aimed to explore the feasibility of preoperative radiotherapy followed by DIEP flap reconstruction in patients with breast cancer requiring mastectomy.

Вмешательства

• Лучевая терапия Preoperative radiotherapy
  Radiotherapy followed by mastectomy and DIEP flap reconstruction
• Лучевая терапия Postmastectomy radiotherapy
  Radiotherapy after mastectomy and DIEP flap reconstruction

Первичные конечные точки

• Patient satisfaction with breasts questionnaire Patient satisfaction of breast [Срок оценки: 24 months after surgery]

Вторичные конечные точки (7)

• Complications of surgery [Срок оценки: 3 months, 12 months, and 24 months]
• Complications of radiotherapy [Срок оценки: 3 months, 12 months, and 24 months after radiotherapy]
• Failure rate of breast reconstruction surgery [Срок оценки: 8 weeks after surgery]
• Patient satisfaction with outcome questionnaire [Срок оценки: 3months, 12 months, and 24 months after surgery]
• Aesthetic evaluation [Срок оценки: 12 months and 24 months after surgery]
• Total pathologic complete response (tpCR) [Срок оценки: up to 4 weeks after surgery]
• 3-year disease free survival (DFS) [Срок оценки: 3 years after diagnosis]

Критерии участия

Критерии включения

• Patients with histological proven invasive breast cancer;
• Clinical T0-3, T4b and N0-3a disease who require neoadjuvant chemotherapy;
• No distant metastasis;
• Adjuvant radiotherapy and who are suitable for DIEP flap reconstruction at the time of mastectomy.

Критерии исключения

• Patients enrolled in other clinical trial which may as influence the outcome;
• Patients received neoadjuvant therapy without radiotherapy indications；
• Disease progression during neoadjuvant chemotherapy；
• Patients of pregnancy or lactation；
• Previous history of diabetes；
• Previous history of heavy smoking.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Guangxi Provincial Cancer Hospital — Nanning
• Henan Provincial Cancer Hospital — Чжэнчжоу
• Hunan Provincial Cancer Hospital — Чанша
• Huashan Hospital of Fudan University — Шанхай
• Yunnan Provincial Cancer Hospital — Куньмин
• Zhejiang Provincial Cancer Hospital — Ханчжоу

Публикации

• Hao S, Hou J, Zhang L, Zhou C, Hou Y, Yu K, Hu Z, Liu G, Di G, Shao ZM, Yu X, Wu J. Protocol for a multicentre, prospective, open-label, randomised controlled trial to compare PROs and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction via a deep inferior epigastric perforator flap (CAPPELLA) in China. BMJ O PMID 39832996

Идентификаторы

NCT: NCT05512286 · CBCSG041

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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