IRCT2015060822610N1已完成2 期
Randomized Phase II study of Vinorelbine Maintenance therapy vs Best Supportive Care in Advanced Non Small Cell Lung Cancer
Investigator0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit(—)
- 性别
- All
入选标准
- •Inclusion criteria was: NSCLC pathology, age of 18 years or older, eastern cooperative oncology group (ECOG) performance statutes (PS) of 0-2, no pervious history of any systemic chemotherapy , advanced stage according AJCC, 7th editionat least one unidimensionally measurable or assessable disease, adequate bone marrow reserve, serum creatinine less than or equal to 1.5 mg/dL or a calculated creatinine clearance greater than or equal to 60 mL/min, bilirubin level less than or equal to 2.0 mg/dL, AST less than or equal to twice the institutional upper limits of normal and or less than or equal to four times the institutional upper limits of normal if the patient had liver metastasis.
- •Exclusion criteria was: administration of systemic chemotherapy, PS 3 and 4 , small cell lung cancer pathology,metastatic from other site,significant or uncontrolled cardiac, metabolic or infectious diseases and symptomatic brain metastasis.
排除标准
- 未提供
研究者
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已完成
不适用
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Study evaluating oral vinorelbine and cisplatin followed by oral vinorelbine alone versus gemcitabine and cisplatin followed by gemcitabine alone in patients with a specific type of lung cancerFirst line Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients with squamous histological typeMedDRA version: 19.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-003531-40-PLPierre Fabre Medicament110
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Study evaluating oral vinorelbine and cisplatin followed by oral vinorelbine alone versus gemcitabine and cisplatin followed by gemcitabine alone in patients with a specific type of lung cancerFirst line Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients withsquamous histological typeMedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-003531-40-ESPierre Fabre Medicament110
