A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 23
- 主要终点
- 2-Partial response
研究概览
简要总结
The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).
详细描述
Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). Response criteria are assessed with RECIST classification by the investigator panel.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
- •Metastatic relapses allowed in not irradiated area.
- •Age between 18 and 70 years
- •Chemonaïve patients
- •At least one measurable target lesion according to recist criteria in non previously irradiated area.
- •Performance status < 2
- •Normal hepatic and renal function, absolute neutrophil count >1,5 giga/l, platelets >100 giga/l.
- •Written informed consent.
- •Life expectancy > 12 weeks.
排除标准
- •SCLC, bronchial-alveolar and neuro-endocrine carcinoma.
- •Previous chemotherapeutic treatment.
- •Symptomatic brain metastases.
- •Superior vena cava syndrome.
- •Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction.
- •Peripheral neuropathy grade ≥
- •Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
- •Hypersensitivity to paclitaxel or polysorbate
- •Pregnancy or breast feeding.
- •Any concomitant radiotherapy, except palliative bone irradiation.
- •Follow-up of the patient impossible.
- •Prisoners.
结局指标
主要结局
2-Partial response
3-Stable disease
1-Complete response
4-Progression
次要结局
- -Toxicity (NCI-CTC criteria)