Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Patient survival, including overall survival and progression-free survival.
研究概览
简要总结
Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.
The major aim of this project is to conduct a prospective, randomized phase III clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone.
Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. According to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.
详细描述
I). Study end points Primary end point: Patient survival, including overall survival and progression-free survival.
Secondary end points:
- Acute toxicity during treatment
- Tumor response rates
- Sites of recurrence
- Long-term complications and quality of life II). Design of study
An open-label, prospective randomized trial with two treatment arms:
- Arm I: Patients receive CCRT with weekly cisplatin only.
- Arm II: Patients receive CCRT with cisplatin plus gemcitabine. III). Study population 1) Number of subjects: A total of 172 patients (86 per treatment arm) will be accrued for this study within 4 years.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed primary squamous cell carcinoma of the uterine cervix.
- •Previously untreated disease.
- •Clinical FIGO stage III-IVa or pelvic/para-aortic lymph node positive by PET examination.
- •No known metastases to supraclavicular nodes or other organs outside the radiotherapy field.
- •Ages eligible: 35 years - 70 years.
- •Patients must have adequate bone marrow, pulmonary, liver and renal function documented before radiotherapy. WBC > 3000/mm3, platelet > 100,000/mm3, serum transaminases (GOT, GPT) < 60 IU/ml, total bilirubin < 1.5mg%, creatinine < 1.4mg% (creatinine clearance > 60 ml/min).
- •Performance status 0 or 1 (see Appendix I).
- •The interval between RT and randomization is not greater than 3 weeks.
- •Patients must have signed informed consent to participate this study.
排除标准
- •Age > 70 or < 35
- •Medical or psychological condition that would preclude treatment.
- •Previous chemotherapy or pelvic RT.
- •Small cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
- •Patient unreliable for treatment completion and follow-up.
研究组 & 干预措施
Gemzar,survival
干预措施: Gemzar (gemcitabine) (Drug)
结局指标
主要结局
Patient survival, including overall survival and progression-free survival.
时间窗: 2012,
次要结局
- 1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life(2013)