NCT01029678已完成2 期
Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC
University Hospital, Limoges5 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年1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
- 48
- 试验地点
- 5
- 主要终点
- Acute toxicity
研究概览
简要总结
The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years
- •Independent patients (based on the score of geriatric frailty: IADL = 0, ADL = 0, no geriatric syndrome, low comorbidity (comorbidity index of Charlson to 3 or 4), depression score 0-1)
- •Performance Status (ECOG) ≤ 1
- •Weight loss <10% of usual weight in the last 3 months
- •Life expectancy greater than 12 weeks
- •Hematologic function: neutrophils> 1.5 x 10**9 / l, hemoglobin> 9.5 g / dl, platelets > 100 x 10**9 / l)
- •Renal function: creatinine clearance ≥ 50 ml / min calculated by the formula of MDRD
- •Normal liver function: bilirubin < Limit of Normal (ULN), SGOT and / or SGPT <2.5 x UNL
- •Respiratory Function: FEV ≥ 40% predicted, PaO2 ≥ 60 mm Hg, KCO ≥ 60% predicted
- •Patient affiliated to a social security regimen or beneficiary of such regimen
- •Informed consent signed
- •The disease
- •Pathological anatomy: CBP non-small cell (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, undifferentiated carcinoma) histologically or cytologically proven
- •Stage IIIAN2 considered inoperable stage IIIB
- •Presence of at least one measurable target
- •Delay at least three weeks between surgery and initiation of treatment
- •No prior treatment with chemotherapy or radiotherapy for lung cancer
排除标准
- •Age < 70 years
- •Performance Status (ECOG) ≥ 2
- •Hematologic function: neutrophils <1.5 x 10**9 / l, hemoglobin <9.5 g / dl, platelets <100 x 10**9 / l)
- •Renal function: creatinine clearance <50 ml / min calculated by the formula of MDRD
- •Hepatic: bilirubin> Upper Limit of Normal (ULN), SGOT and / or SGPT> 2.5 x ULN
- •Respiratory Function: FEV <40% predicted, KCO <60% predicted, PaO2 <60 mmHg
- •Peripheral neuropathy grade> 1
- •Unstable cardiac pathology requiring treatment (heart failure, angor of effort, arrhythmia) or previous myocardial infarction older than 12 months
- •Deafness not paired or deafness requiring major achievement of an audiogram-cons may indicate taking cisplatin
- •Neurological or psychiatric disorders prohibiting the understanding of the test
- •Previous history of cancer except basal cell cancer, carcinoma in situ of the cervix treated or any other cancer treated with surgery alone or radiotherapy alone extra-thoracic recurrence-free 5 years
- •Significant malabsorption syndrome or disease affecting the functioning of the gastrointestinal tract
- •The disease
- •Pathological anatomy: Bronchioloalveolar carcinoma, neuroendocrine carcinoma, small cell carcinoma
- •Metastatic disease
- •Pleural drain
- •Carcinomatous lymphangitis
- •Operable Cancer
- •Previously treated for lung cancer disease: radiotherapy, chemotherapy, hormonal therapy, endobronchial suctioning older less than eight days
研究组 & 干预措施
experimental
Experimental
干预措施: Cisplatin IV (Drug)
experimental
Experimental
干预措施: Vinorelbine (Drug)
experimental
Experimental
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Acute toxicity
时间窗: during treatment and during the 4 weeks following the end of treatment
次要结局
- Late toxicity(6 months after the end of the treatment)
- Overall response rate(4 weeks after treatment)
研究者
研究点 (5)
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