NCT00251888已完成1 期
Etude de Recherche de Dose de l'Association Irinotecan (Campto(R)) - Cisplatine (Cisplatyl(R)) Avec la radiothérapie Pelvienne Dans Les Cancers avancés du Col de l'utérus.
ARCAGY/ GINECO GROUP4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2002年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer
研究概览
简要总结
Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.
详细描述
To determine the maximum and the recommended tolerated dose of irinotecan with increasing doses associated with weekly cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer, IIB-IVA FIGO stage.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven primitive epidermoid or andenocarcinoma Cervix
- •FIGO stage IIB (obviously parameter attack), III or IVA
- •No previous chemotherapy nor radiotherapy
- •Patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma
- •PS ECOG < 2
- •Life expectancy > 12 weeks
- •Written consent given
排除标准
- •Other malignant cervix tumor histology
- •Visceral remotly metastasis
- •Other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer
- •Anormal labs values
- •Peripheric neuropathy CTC > 2
- •Auditory loss > 2
- •Cardiopathy
- •Inflammatory digestive pathology
- •Evolutive infection
- •Other experimental concommitant treatment
- •Lacting or pregnant women
结局指标
主要结局
To determine the maximum tolerated dose of irinotecan associated with cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer
次要结局
- local and general relapse frequency
- progression free survival
- the global response rate judged on standard clinical criteria, echography, tomodensiometry, and MRI. The histologic response rate will be appreciated in patients who had a second surgery after pelvic radiochemotherapy
- To evaluate :
- global survival
研究者
研究点 (4)
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