Phase II, Prospective, Randomized, Non-comparative Study of Treatment With Induction Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation or Definitive Chemoradiation in Invasive Locally Advanced Carcinomas of Uterine Cervix.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The purpose of this phase II study is to determine the survival free disease of patients diagnosed with invasive locally advanced carcinomas of uterine cervix treated with induction chemotherapy with cisplatin and gemcitabine followed by chemoradiation and definitive chemoradiation.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Advanced carcinoma of uterine cervix histological confirmed.
- •Indication for definitive chemoradiation treatment;
- •Measurable disease by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria;
- •Age between 18 years old and 70 years old;
- •Adequate bone marrow and organ function defined by laboratory values;
- •Non evidence of disease in para-aortic lymph node;
排除标准
- •Previous treatment with Chemotherapy or radiotherapy
- •Previous surgery for primary tumor;
- •Distant metastasis;
- •Performance status according to Eastern Cooperative Oncology Group greater than 2;
- •Peripheric neuropathy greater than grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 3.0;
- •Significant Cardiac disease (history of and/or active disease);
- •Other treatment for cancer, including hormonotherapy;
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements;
研究组 & 干预措施
Chemoradiotherapy
Cisplatin, radiotherapy and brachytherapy
干预措施: Brachytherapy (Radiation)
Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
干预措施: cisplatin (Drug)
Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
干预措施: Gemcitabine (Drug)
Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
干预措施: Radiotherapy (Radiation)
Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
干预措施: Brachytherapy (Radiation)
Chemoradiotherapy
Cisplatin, radiotherapy and brachytherapy
干预措施: cisplatin (Drug)
Chemoradiotherapy
Cisplatin, radiotherapy and brachytherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Disease free survival
时间窗: From the randomization until the end of the treatment - up to 36 month.
次要结局
- Locoregional disease control rate(36 month after the end of treatment.)
- Acute and chronic toxicity in both arms(From the randomization until the end of the treatment.)
- Overall survival(36 month after the end of the treatment.)
- Response rate(36 month after the end of the treatment.)