NCT00418743Unknown不适用
A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 24
研究概览
简要总结
The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.
详细描述
Determined treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Small-cell lung cancer.
- •Patients who, after (at least) a first line of chemotherapy based on platinum, had a partial response and then progressed, or who had a complete response and then relapsed within three months following the last course of this first-line therapy.
- •Measurable or assessable disease.
- •Life expectancy >2 months.
- •Patients with a therapeutic risk level of <5 points (see section 6: "Treatment flowchart").
- •Age >18 years;
- •Performance status (WHO) <2;
- •One measurable target lesion in a non irradiated region;
- •Prior radiotherapy authorized unless it targeted the only measurable lesion;
- •Biological criteria: WBC >2000/mm3, PMN >1500/mm3, platelets >100 000/mm3, creatinemia <2 x ULN, bilirubinemia <ULN, ALT and AST <2.5 x ULN (< 5 N if liver metastases)
- •normal ECG
- •written informed consent.
排除标准
- •Non small-cell lung cancer.
- •No objective response to platinum-based therapy
- •Complete response lasting more than three months after the last course of first-line treatment.
- •Symptomatic brain metastases.
- •Bone metastases, carcinomatous lymphangitis, ascites or pleurisy as sole assessable disease manifestations.- Concurrent participation in another clinical trial.
- •Therapeutic risk level of 6 points or more (see table)
- •Uncontrolled clotting disorders;
- •Uncontrolled severe infection;
- •History of another malignancy, except for cervical carcinoma in situ or basocellular cancer that are considered cured;
- •Psychological, familial, sociological or geographic circumstances preventing treatment follow-up as defined in the protocol;
- •Patients deprived of their rights for administrative or legal reasons.
研究者
研究点 (24)
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