Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
The aim of this clinical trial is to assess the oncologic safety of minimally invasive pelvic exenteration in patients with recurrence or persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). The primary aim is to assess the 3-year disease-free survival (DFS). The secondary aim is to assess the 3-year overall survival (OS), the intraoperative and post-operative complication rate, and the patient's quality of life.
详细描述
Patients will be considered pre-operatively eligible in case of recurrence/persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). Histological diagnosis of recurrent or persistent disease obtained with biopsy performed during examination under anesthesia or US-guided biopsy, or RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria of progressive disease are required, as by standard clinical practice. All patients will undergo MRI pelvic scan and PET/CT scan within one month before the surgery, as by standard clinical practice. After obtaining oral and written informed consent, patients will be registered. Pelvic exenteration will be performed with the aim of removing a single specimen with negative surgical margins.
A mini-laparotomy of up to 7 cm will be allowed to complete the reconstructive phase of the procedure.
Registration data has to be entered to an electronic Case Report Form (eCRF). The Principal Investigator (PI) of the study will independently take responsibility for the development of an electronic Case Report Form (CRF) for data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosis of recurrent or persistent vaginal or cervical cancer
- •Proven histological diagnosis of squamous carcinoma, adenocarcinoma or adenosquamous carcinoma
- •Isolated central pelvic recurrence
- •MRI-measured maximum tumor diameter ≤ 50 mm
- •Age > 18 years
- •Patients who have signed an approved informed consent form
- •Patients must be suitable for surgery
- •ECOG Performance Status of 0, 1 or 2 (Eastern Cooperative Oncology Group)
排除标准
- •Para-aortic lymph nodes with a short-axis diameter ≥ 15 mm on MRI scan and/or SUV max ≥ 2.5 on PET/CT scan
- •Involvement of lateral pelvic structures (on preoperative imaging or during examination under anaesthesia)
- •Sciatic nerve involvement (at pre-operative imaging or during examination under anaesthesia)
- •Distant metastasis at PET/CT scan
- •Any histological type other than squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma
- •Contraindications to surgery
- •Serious concomitant systemic disorders incompatible with surgery or minimally invasive surgery (at the discretion of the investigator)
- •Women unable to tolerate prolonged lithotomy and steep Trendelenburg positions
- •Women with secondary invasive neoplasm in the last 5 years
研究组 & 干预措施
Recruited patients
Cervical cancer or vaginal cancer patients with recurrent/persistent disease assessed for elegibility
干预措施: Minimally invasive pelvic exenteration (Procedure)
结局指标
主要结局
Disease free survival (DFS)
时间窗: From the enrollment for the following three years.
The primary aim is to assess the 3-year disease free survival
次要结局
- Overall survival (OS)(Survival time is calculated from the date of surgery until the date of death from any cause, or for patients still alive to the date of last clinical follow-up or contact, assessed up to 100 months.)
- Intraoperative complication rate(During the procedure)
- Post-operative complication rate(One month and six months after surgery)
- Health Related Quality of Life (HRQoL) n.1(At baseline and one month, six months, one years and two years after surgery.)
- Health Related Quality of Life (HRQoL) n. 2(At baseline and one month, six months, one years and two years after surgery.)
研究者
Bizzarri Nicolò
Medical Doctor in the Gynecologic Oncology Department
Fondazione Policlinico Universitario Agostino Gemelli IRCCS