Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

Официальное название

The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial

Обзор

In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.

Подробное описание

An increasing proportion of breast cancer patients treated by mastectomy wish for a breast reconstruction. If post-mastectomy radiation therapy is recommended, the reconstruction is often delayed until 6 - 12 months after completion of chemotherapy and radiation therapy due to risk of complication that might delay adjuvant treatment. At this time the native skin over the removed breast cannot be used in the reconstruction, resulting in a suboptimal aesthetic outcome. In the delayed-immediate reconstruction method, a skin sparing mastectomy and reconstruction with implant is performed at primary surgery, to save the native skin under radiation therapy, thereby improving the chance for a good aesthetic outcome at the final delayed reconstruction. In this trial breast cancer patients treated by mastectomy and loco-regional radiation therapy is randomized to either delayed reconstruction or delayed-immediate reconstruction. The complication rate as well as morbidity, aesthetic outcome and psychological well-being after delayed-immediate reconstruction will be compared with delayed reconstruction

Вмешательства

• Процедура Delayed-immediate reconstruction
  Skin sparing mastectomy and reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Final reconstruction with any reconstructive procedure 6-12 months after completion of chemotherapy and RT.
• Процедура Delayed reconstruction
  Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT

Первичные конечные точки

• Number of patients with complications with surgical intervention [Срок оценки: 1 year after final reconstruction]

Вторичные конечные точки (10)

• Number of patients with complications without surgical intervention [Срок оценки: 1 year after final reconstruction]
• Depression [Срок оценки: 10 years post-final reconstruction]
• Fear of cancer recurrence [Срок оценки: 10 years post-final reconstruction]
• Patient´s satisfaction and quality of life (QoL) [Срок оценки: 10 years post-final reconstruction]
• Timely initiation of adjuvant therapy [Срок оценки: 1 year]
• Degree of patient reported morbidity regarding body image, painsensory disturbanses and feeling og lymphoedema [Срок оценки: 10 years post-final reconstruction]
• Number of patients with lymphoedema [Срок оценки: 10 years post-final reconstruction]
• Number of patients with restricted range of motion of the shoulder [Срок оценки: 10 years post-final reconstruction]
• Number of patients with capsular contracture [Срок оценки: 10 years post-final reconstruction]
• Aesthetic outcome [Срок оценки: 10 years post-final reconstruction]

Критерии участия

Критерии включения

• Woman >18 years who are offered a mastectomy for invasive breast can-cer pT1-3, pN0-N3, M0 and wish reconstruction. The patient can be inclu-ded no matter the status of estrogen receptor, progesterone receptor, malignancy grade, and HER2 status.
• The patient is a candidate for loco-regional radiation therapy according to national or institutional guidelines.
• Highly selected patients with inflammatory breast cancer, namely those with complete or near complete response to neoadjuvant systemic thera-py judged by imaging and clinical examination before surgery. Any skin edema and clinical signs of skin involvement must have disappeared during systemic therapy. It is highly recommended that the decision to offer an inflammatory breast cancer patient inclusion in the DBCG RT Recon trial is made during a multidisciplinary team conference.
• Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatment and other targeted therapies used in the adjuvant setting either as new standard or as part of a trial during the course of the trial is accepted.
• Neoadjuvant chemotherapy and primary systemic therapy of an operable breast cancer is accepted.
• Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist esti-mates a low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situ coli, melanoma in situ, basal cell carcino-ma of the skin, squamous cell carcinoma of the skin.
• Life expectancy minimum 10 years.

Критерии исключения

• Pregnant or lactating.
• Previous breast cancer or Ductal carcinoma in Situ (DCIS).
• Bilateral breast cancer.
• Previous radiation therapy to the chest region.
• Previous non-breast malignancy (not including carcinoma in situ of the cervix or colon, melanoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin) within 5 years.
• Conditions indicating that the patient cannot go through breast reconstruction, the radiation therapy or follow up.
• Not being able to participate due to language or other personal issues.
• Life expectancy less than 10 years.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 8 центров

• Åbenrå Sygehus — Aabenraa
• Ålborg Universitetshospital — Aalborg
• Århus Universitets Hospital — Aarhus
• Gentofte Hospital/Herlev Hospital — Copenhagen
• Esbjerg Sygehus — Esbjerg
• Sjællands Universitetshospital — Roskilde
• Vejle Sygehus — Vejle
• Viborg Sygehus — Viborg

Публикации

• Kaidar-Person O, Nissen HD, Yates ES, Andersen K, Boersma LJ, Boye K, Canter R, Costa E, Daniel S, Hol S, Jensen I, Lorenzen EL, Mjaaland I, Nielsen MEK, Poortmans P, Vikstrom J, Webb J, Offersen BV. Postmastectomy Radiation Therapy Planning After Immediate Implant-based Reconstruction Using the European Society for Radiotherapy and Oncology-Advisory Committee in Radiation Oncology Practice Consen PMID 32988717

Идентификаторы

NCT: NCT03730922 · DBCG RT Recon

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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