Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 974
- 试验地点
- 1
- 主要终点
- 3-year DFS
研究概览
简要总结
The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.The SHAPE trial was designed to answer the clinical question of whether simple hysterectomy could be performed instead of radical hysterectomy in low-risk early stage cervical cancer but not the surgical approach. The favorable oncological outcome observed in SHAPE despite 75% of patients were treated with minimally invasive approach suggests that this approach may be safe. However, the trial was not designed to analyze oncological outcomes from surgical approach.
详细描述
The Laparoscopic Approach to Cervical Cancer (LACC) Trial showed that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. Since then, the standard of care in terms of surgical approach to radical hysterectomy has been considered the laparotomy. More recently, the SHAPE trial results were presented showing that in patients with low-risk cervical cancer (defined as FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: < 10 mm on LEEP/cone and < 50% depth on MRI) simple hysterectomy was not inferior to radical hysterectomy for what concerned pelvic recurrence, with less complications and better quality of life. However, SHAPE trial was not designed to assess the surgical approach.
The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.
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
- •Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma of uterine cervix
- •FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤10mm on conization specimen
- •FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤50% at pre-conization MRI-scan or "expert" US-scan.
- •Age ≥18 years
排除标准
- •Neuroendocrine, clear cell, serous carcinoma
- •Depth of infiltration >10 mm on conization specimen
- •Depth of infiltration >50% at pre-conization imaging
- •Cervical tumor >2 cm
- •Diagnosis on inadvertent hysterectomy
- •Neoadjuvant chemotherapy
- •Previous pelvic radiotherapy
- •Pregnant women
- •Contraindications to surgery
- •Lymph nodes >15 mm short axis
- •Fertility sparing treatment or desire
- •Recurrent cervical cancer
- •Time between cervical cancer diagnosis and hysterectomy >4 months if conization with tumor negative margins
- •Time between cervical cancer diagnosis and hysterectomy >3 months if conization with invasive tumor positive margins
结局指标
主要结局
3-year DFS
时间窗: 36 months after surgery
disease free survival at 3 years
次要结局
- intra-operative and post-operative complications(36 months after surgery)
- Rate of upstage after surgery(36 months after surgery)
- 3-year recurrence rate (including pelvic recurrence rate)(36 months after surgery)
- 3-year overall survival(36 months after surgery)
研究者
Bizzarri Nicolò
MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS