Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 455
- 试验地点
- 7
- 主要终点
- Progression-free survival rate
研究概览
简要总结
Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.
详细描述
This clinical trial enrolled participants with locally advanced cervical cancer with positive pelvic lymph nodes below the common iliac region diagnosed by Positron emission tomography-computed tomography(PET-CT). Participants should be able to receive concurrent cisplatin chemotherapy. No anti-tumor treatment was given before randomization. Participants will be randomly assigned to two groups. The study group will receive radiotherapy of pelvic and para-aorta, concurrent chemotherapy and brachytherapy, and the control group will receive pelvic radiotherapy, concurrent chemotherapy and brachytherapy.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients voluntarily participated in the study and signed the informed consent
- •18-75 female
- •Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma
- •According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ⅠB2 - ⅣA with positive pelvic lymph nodes and negative common iliac and paraaortic lymph nodes diagnosed by PET-CT
- •Cisplatin chemotherapy is acceptable
- •Eastern Cooperative Oncology Group(ECOG) score 0-1
- •The expected survival was more than 6 months
- •Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test
- •According to the judgment of the researcher, those who can comply with the trial protocol
排除标准
- •Uncontrolled severe infection
- •Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years
- •The patient has received anti-tumor treatment
- •Liver cirrhosis, decompensated liver disease, chronic renal insufficiency and renal failure
- •History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency disease
- •Myocardial infarction, severe arrhythmia and grade 2 or more congestive heart failure (NYHA classification)
- •Patients with previous pelvic artery embolization
- •Previous radiotherapy for pelvic malignant tumor
- •There was a history of severe allergic reaction to platinum containing chemotherapy drugs
- •Complications, need to be taken during the treatment of liver and kidney function damage drugs, such as tuberculosis
- •The patients who could not understand the content of the experiment and could not cooperate and refused to sign the informed consent
- •Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study
结局指标
主要结局
Progression-free survival rate
时间窗: 3-year
the percentage of participants in the group whose disease is likely to remain stable
次要结局
- Quality of life (QOL) assessed by EORTC QLQ-C30 v3(1-month and 6-month)
- Quality of life (QOL) assessed by EORTC QLQ-CX24(1-month and 6-month)
- Distant recurrence rate(3-years)
- Overall survival rate(3-year)
- Para-aortic recurrence rate(3-year)
- Side effects(3-year)