NCT00985855已完成2 期
Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study
Institut de Cancérologie de la Loire1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)
研究概览
简要总结
Phase II, randomised, controlled, non comparative study with 2 parallel groups:
- Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.
- Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.
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
- •Non-Small-Cell Lung cancer cytologically or histologically proved
- •Stage III AN2 inoperable or non resectable
- •presence of at least one one dimension measurable target (at least 10 mm with spiral tomodensitometry)
- •Possibility to include all targets in one irradiation field
- •Age of 18 to 70
- •Patients non previously treated
- •Performance Status 0 or 1
- •Loss of weight ≤10% in the 3 last months
- •Neutrophil ≥ 1500/mm3 and platelets ≥ 100000/mm3
- •Creatinine clearance ≥ 60 ml/min
- •total bilirubin ≤ 1,5N and ASAT ALAT ≤ 2,5N
- •Respiratory function normal: VEMS ≥ 40% theorical, DLCO/VA ≥ 50% theorical and PaO2 ≥ 60 mmHg
- •Signed inform consent form
- •Compliance to radiotherapy 66 Gy with dosimetry V20 ≤ 35% and pulmonary mean dose≤20 Gy
排除标准
- •Pretreated bronchial carcinoma, excepted endoscopic deobstruction
- •operable bronchial carcinoma
- •small cell lung cancer, composite cancer, neuroendocrine cancer, broncho alveolar cancer
- •superior vena cava syndroms
- •puncturable pleural effusion
- •metastatic lung cancer
- •Stage IIIb cancer with neoplastic pericarditis
- •Previous thoracic irradiation
- •severe cardiac disease in the 12 months before inclusion
- •interstitial lung disease
- •anti-EGFR and anti-VEGF treatments
- •hypersensitivity to murine proteins and allergies to protocol drugs
- •uncontrolled infectious state
- •HIV patient
- •corticoid definitive contraindication
- •péripheric neuropathy grade≥2
- •neurologic, psychiatric and organic disorder
- •past or concomitant cancer excepted treated skin baso-cellular cancer or in situ cervical cancer, or any cancer only surgically treated for 5 years
- •breastfeeding woman
研究组 & 干预措施
Cisplatin, vinorelbine
Experimental
patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.
干预措施: cisplatin, vinorlebine, cetuximab (Drug)
Cisplatin, etoposide
Experimental
patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.
干预措施: cisplatine, etoposide, cetuximab (Drug)
结局指标
主要结局
rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)
时间窗: End of concomitant treatment (Day 71)
次要结局
未报告次要终点
研究者
研究点 (1)
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