Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,956
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.
详细描述
All eligible patients will be divided into the following two treatment groups nonrandomly.
Image staging group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy).
Surgery staging group: open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be conducted within 28 days postoperatively.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients with good compliance, voluntarily signed the informed consent form and participated in the study.
- •Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
- •Stage (FIGO2018): IB3, IIA2, IIB-IVA;
- •ECOG score: 0 ~ 1;
- •The expected survival >6 months;
- •The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial.
排除标准
- •Activity or uncontrol severe infection;
- •Liver cirrhosis or other decompensated liver disease;
- •A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;
- •Chronic renal insufficiency or renal failure;
- •Other malignancies were diagnosed within five years or needed treatments;
- •Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);
- •The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
- •A history of pelvic artery embolization;
- •A history of pelvic radiotherapy;
- •A history of partial hysterectomy or radical hysterectomy;
- •A history of severe allergic reaction to platinum drugs;
- •The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;
- •Patients who cannot understand the research regimen and refuse to sign the informed consent form;
- •Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
研究组 & 干预措施
Image staging group
Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
干预措施: Concurrent chemoradiation (Radiation)
Surgery staging group
Open/minimally invasive para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
干预措施: Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation (Procedure)
结局指标
主要结局
PFS
时间窗: 3 years
Progression-free survival
次要结局
- OS(3 years and 5 years)
- Complication(1 year)
研究者
Dongling Zou
Director of Gynecologic Oncology Department
Chongqing University Cancer Hospital