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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 590
- 试验地点
- 8
- 主要终点
- Number of patients with complications with surgical intervention
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of patients with complications with surgical intervention
时间窗: 1 year after final reconstruction
Number of patients with complication deeming surgical intervention necessary (excluding percutaneous drainage and antibiotic treatment for inflammation in cases without need for open drainage): * Infection * Hematoma * Loss of implant/expander * Necrosis * Seroma
次要结局
- Fear of cancer recurrence(10 years post-final reconstruction)
- Number of patients with complications without surgical intervention(1 year after final reconstruction)
- Number of patients with lymphoedema(10 years post-final reconstruction)
- Aesthetic outcome(10 years post-final reconstruction)
- Depression(10 years post-final reconstruction)
- Patient´s satisfaction and quality of life (QoL)(10 years post-final reconstruction)
- Timely initiation of adjuvant therapy(1 year)
- Degree of patient reported morbidity regarding body image, painsensory disturbanses and feeling og lymphoedema(10 years post-final reconstruction)
- Number of patients with restricted range of motion of the shoulder(10 years post-final reconstruction)
- Number of patients with capsular contracture(10 years post-final reconstruction)
研究者
Tove Filtenborg Tvedskov
Consultant, DMSc, Phd, associated professor
Danish Breast Cancer Cooperative Group