NCT00421096终止2 期
Stage IB2 to IVA Uterine Cervical Cancer: Phase 2 Study to Assess a New Therapeutic Sequence Associating a Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age between 18 and 70 years old
- •Cervical uterine cancer (epidermoid or adenocarcinoma, stage:from IB> or = 4 cm to IV, according to FIGO classification) histologically proven
- •Measurable lesions,clinically and by MRI assessed
- •PS-WHO < or = 2 ou Karnofsky Index >70 per cent
- •Life expectancy > 3 months
- •Hematologic function: leukocytes < or = 3 G/l, polynuclear neutrophil leukocytes > or = 1.5 G/l, platelets > or = 100 G/l, hemoglobin > or = 10 g/dl
- •Hepatic function: ASAT and ALAT < 2.5 ULN
- •Renal function: creatininemia < 1.5 ULN, clearance > 60 ml/min
- •No prior chemotherapy or radiotherapy
- •Contraception
- •Written informed consent signed
排除标准
- •Stage IB < 4 cm or IVB
- •Other histology than epidermoid or adenocarcinoma
- •Distant metastases, including sus-clavicular adenopathy
- •Contraindication to MRI
- •Pregnant or lactating woman
- •Auto-immune disease
- •Peripheric neuropathy, autograft or homograft, psychiatric disease
- •Prior cancer (except cutaneous basocellular carcinoma and uterine cervical carcinoma in situ)
- •Active infection
- •Other clinical trial with an experimental drug
- •Known positive serology (HIV, HbC, HbS)
研究组 & 干预措施
patient with cervix cancer
Experimental
will receive gemcitabine + cisplatin + radiotherapy
干预措施: Gemcitabine (Drug)
patient with cervix cancer
Experimental
will receive gemcitabine + cisplatin + radiotherapy
干预措施: Radiotherapy (Procedure)
patient with cervix cancer
Experimental
will receive gemcitabine + cisplatin + radiotherapy
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3 years after the end of study treament
次要结局
- Global survival(5 years after the end of study treatment)
- safety(untill 5 years after study treatment)
研究者
研究点 (2)
Loading locations...
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