A Phase II Study of Cisplatin With Intravenous and Oral Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemotherapy With Oral Vinorelbine and Cisplatine for Locally Advances Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Disease controle
研究概览
简要总结
Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles during RT(66 Gy/6.5 w).
详细描述
Vinorelbine (NVB) + CDDP is considered a standard trt in induction or concomitantly with RT (Vokes, Fournel, Krzakowski). NVBo simplifies the administration of trt and provides the same efficacy as intravenous NVB (NVBiv). In order to assess this and to improve the tolerance, a trial was started with NVBiv and NVBo + CDDP as induction followed by a fractionated administration of NVBo + CDDP during RT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically confirmed stage IIIA (only N2),
- •dry IIIB previously untreated inoperable NSCLC,
- •18 to 75 years old,
- •Karnofsky Performance Status (KPS) ≥ 80%,
- •weight loss ≤ 10% within the previous 3 months,
- •normal organ functions were eligible.
- •at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) [10].
排除标准
- •stages I, II, IIIA (excepted N2), IIIB with pleural effucion and stage IV,
- •pregnant or breastfeeding women. Women of Childbearing Age: Women of childbearing potential should take reliable contraceptive measures
- •Symptomatic Neuropathy > grade 1,
- •associated Pathology and/or not controled diseases(cardiac insuficiency, myocardial infarction within 3 months before the inclusion ; hypertension, arythmia or uncontroled hypercalcémia; infection requiering iv antibiotic administration within 2 weeks before inculion),
- •other associated cancer with the exception of cervical carcinoma in situ or skin cancer baso-cellular correctely treated,
- •Previous treatment with an other antineoplasic,
- •Known hypersensibility to drugs with a similar chemical structure ti this studied.
- •important malabsorbtion syndrom or disease of gastro-intestinal track,
- •Participation to another clinical trial within 30 days before inclusion
研究组 & 干预措施
Vinorelbine cisplatin radiotherapy
Induction period + radio chemotherapy
干预措施: Vinorelbine cisplatin radiotherapy (Drug)
结局指标
主要结局
Disease controle
时间窗: up to 3 years
次要结局
- - duration of response (DR)(up to 3 years)