A Multicenter, Non-inferiority Trial to Compare the Effectiveness and Safety of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-free Techniques Versus Abdominal Radical Hysterectomy in Patients With Stage IB2 Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 524
- 试验地点
- 17
- 主要终点
- 4.5-year Disease-free Survival
研究概览
简要总结
The goal of this clinical trial is to learn if laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) works to treat FIGO stage IB2 cervical cancer as good as abdominal radical hysterectomy (ARH). It will also learn about the safety of LRH-MTF. The main questions it aims to answer are:
Does LRH-MTF achieve a non-inferior disease-free survival rate at 4.5 years post - operation compared to ARH? What complications do patients have during and after the operation when receiving LRH-MTF? Researchers will compare LRH-MTF to ARH to see if LRH-MTF works no worse than ARH in treating FIGO stage IB2 cervical cancer.
Participants will:
- Undergo either LRH-MTF or ARH as assigned by randomization.
- Visit the hospital for follow-up according to the study schedule for various examinations including blood tests, imaging studies, and assessment of complications.
- Complete quality-of-life questionnaires such as EORTC QLQ-C30, QLQ-CX24, FSFI, and FSDS-R at baseline (pre-operation) and specific time points during the follow - up period (post-operation 6 months, 1 year, 2 years, 3 years, 4.5 years).
详细描述
A progress report will be conducted within 4 weeks after all participants have completed their 6-month postoperative visit (the 5th visit). The report will be performed by an independent third-party statistical team, which will provide a comprehensive analysis of the safety data, baseline characteristic, and perioperative indicators.
The study will perform one final analysis.
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
- •Inclusion Criteria:
- •1.1 Females aged 18 to 65 years old. 1.2 Histologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- •1.3 FIGO 2018 stage IB
- •1.4 The maximum diameter of the cervical lesion measured by MRI is >2 cm and ≤4 cm. For those with MRI contraindications, PET/CT, CT, or ultrasound can be used as alternatives.
- •1.5 Scheduled to receive type C (Q - M classification) radical hysterectomy. 1.6 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •1.7 Willing to participate in this trial and sign the informed consent form. 1.8 Able to cooperate and complete follow - up and relevant examinations. 1.9 For pre - menopausal women, a negative pregnancy test within 30 days before surgery.
- •1.10 Laboratory test indicators of vital organs meet the standards
排除标准
- •2.1 Special pathological types (gastric - type adenocarcinoma, neuroendocrine carcinoma, clear cell carcinoma, carcinosarcoma, etc.).
- •2.2 Imaging examinations suggest pelvic or para - aortic lymph node metastasis (MRI or CT shows a short - axis diameter of ≥1.5 cm, or SUV ≥2.5), or histopathology indicates lymph node metastasis.
- •2.3 History of pelvic and abdominal radiotherapy. 2.4 History of neoadjuvant chemotherapy. 2.5 Uterus larger than that at 10 weeks of pregnancy. 2.6 Contraindications for surgery and anesthesia (such as severe medical comorbidities).
- •2.7 Patients who cannot tolerate the Trendelenburg position. 2.8 Patients who cannot cooperate with treatment and follow - up. 2.9 Pregnant patients. 2.10 History of other malignancies, except for those who have been cancer - free for more than 3 years with no current evidence of tumor recurrence.
研究组 & 干预措施
LRH-MTF
Laparoscopic radical hysterectomy incorporating modified tumor-free techniques
干预措施: Laparoscopic radical hysterectomy incorporating modified tumor-free techniques (Procedure)
ARH
Abdominal radical hysterectomy
干预措施: Abdominal radical hysterectomy (Procedure)
结局指标
主要结局
4.5-year Disease-free Survival
时间窗: From the surgery to the 4.5 years after the end of treatment
The time from the surgery until the first recurrence or death from any cause within 4.5 years after surgery. Recurrence needs to be confirmed by histopathology and/or imaging. If pathological evidence cannot be obtained, recurrence should be determined by two or more detection methods, and adjudicated by an independent Endpoint Event Evaluation Committee.
次要结局
- 4.5-year Overall Survival(From the surgery to the 4.5 years after the end of treatment)
- Operating time(From the start to the end of the surgery up to 24 hours)
- Postoperative pain(From surgery to the third day after surgery)
- Gastrointestinal function recovery(From the end of surgery to the first postoperative flatus at 7 days.)
- Length of hospital stay(From hospitalization to discharge up to 90 days.)
- Pattern of Reccurence(From surgery to the 4.5 years after the end of treatment)
- Estimated surgical blood loss(From the start to the end of the surgery up to 24 hours)
- Treatment cost(From enrollment to the 4.5 years after the end of treatment)
- EORTC QLQ - C30 scale(From enrollment to the 4.5 years after the end of treatment)
- EORTC QLQ - CX24 Scale(From enrollment to the 4.5 years after the end of treatment)
- FSFI Scale(From enrollment to the 4.5 years after the end of treatment)
- FSDS - R Scale(From enrollment to the 4.5 years after the end of treatment)
研究者
xiang yang
Professor
Peking Union Medical College Hospital