Randomized Clinical Trial Comparing the Oncology Outcome and Safety of QM-B and QM-C Hysterectomy for Early Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 538
- 试验地点
- 1
- 主要终点
- Rate of overall survival
研究概览
简要总结
The goal of this clinical research study is to compare the long-term outcomes and safety of Querleu-Morrow-B(QM-B) and Querleu-Morrow-C(QM-C) hysterectomy for early cervical cancer. In this study, the surgical approach for QM-B and QM-C hysterectomy will be abdominal.
详细描述
Primary Objective:
To compare 5-year overall survival and 5-year disease-free survival amongst patients who undergo a QM-B hysterectomy versus those who undergo a QM-C hysterectomy for early stage cervical cancer.
Secondary Objectives:
Compare operation time between arms. Compare blood loss between arms. Compare blood transfusion between arms. Compare intraoperative complications between arms. Compare postoperative complications between arms. Compare quality of lifes between arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have signed an approved Informed Consent
- •18.5≤BMI<28
- •Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
- •Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, stage IB1, stage IB2, or stage IIA1 disease(FIGO 2018).
- •Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or
- •Patients undergoing the Non-Fertility-Sparing surgery.
- •Patients undergoing abdominal surgery.
排除标准
- •The life expectancy of the patient is less than 6 months.
- •Patients with serious medical diseases.
- •Patients with contraindications to surgery or anesthesia.
- •Preoperative imaging studies suggest metastasis to pelvic lymph nodes or para-aortic lymph nodes.
- •Patient asks to preserve fertility.
- •The patient requested direct radiation therapy.
- •Patients with adjuvant radiotherapy or chemotherapy before surgery.
- •Patients judged by the investigator to be unsuitable to participate in this trial.
结局指标
主要结局
Rate of overall survival
时间窗: 5 years from surgery
Compare treatment equivalence
Rate of disease-free survival
时间窗: 5 years from surgery
Compare treatment equivalence
次要结局
- Costs(6 months from surgery)
- Rate of intraoperative complications(Intra-operatively)
- Operation time(Intra-operatively)
- Quality of life Questionnaires(6 months from surgery)
- Volume of blood loss(Intra-operatively)
- Rate of blood transfusion(Intra-operatively)
- Rate of postoperative complications(6 months from surgery)
- Pelvic Floor Distress Inventory Questionnaire(5 years from surgery)
研究者
Chen Chunlin
Director, Head of Obstetrics and Gynecology, Principal Investigator, Clinical Professor
Southern Medical University, China