EUCTR2009-012413-21-FR进行中（未招募）1 期
Etude de phase II évaluant un traitement par cisplatine et vinorelbine orale administrés de façon hebdomadaire et radiothérapie concomitante chez le sujet âgé indépendant atteint de cancer broncho-pulmonaire non à petites cellules localisé non opérable. - RACCOSA
CHU Limoges0 个研究点目标入组 49 人开始时间: 2009年6月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patient older than 70 years
- •- Independent Patient (IADL= 0, ADL = 0, no geriatric syndrome, low comorbidity (Charlson comorbidity index of 3 or 4), depression score of 0-1 )
- •- Performans Status (ECOG) < 1
- •- Life expectancy greater than 12 weeks
- •- Haematological function: neutrophils> 1.5 x 109 / l, hemoglobin> 9.5 g / dl, platelets> 100 x 109 / l
- •- Renal function: creatinine clearance >= 50 ml / min calculated by the formula of Levey-abbreviated MDRD
- •- Normal liver function: bilirubin
- •- Respiratory function: VEMS >= 40% theoretical, PaO2 >= 60 mm Hg, KCO >=60% theoretical
- •- Weight loss <10% of usual weight in the last 3 months
- •- Informed Consent given
- •- Non-small cell lung cancer proven cytological or histologically , inoperable stage - IIIAN2 or stage IIIB
- •- Presence of at least one measurable lesion
- •- At least three weeks between surgery and initiation of treatment
- •- No previous treatment with chemotherapy or radiotherapy for lung cancer
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Performans Status (ECOG)> 2
- •- Haematological function: neutrophils <1.5 x 109 / l, hemoglobin <9.5 g / dl, platelets <100 x 109 / l
- •- Renal function: creatinine clearance <50 ml / min calculated by the formula of Levey-abbreviated MDRD
- •- Hepatic bilirubin> ULN, SGOT and / or SGPT> 2.5 x ULN
- •- Respiratory Function: FEV <40% theoretical KCO <60% theoretical, PaO2 <60 mmHg
- •- Peripheral neuropathy grade> 1
- •- Unstable cardiac pathology requiring treatment
- •- Deafness
- •- Neurological or psychiatric disorders
- •- Uncontrolled infection
- •- All other organic diseases that may prevent the inclusion in the trial
- •- Suscebibility to steroids
- •- Suscebibility to cisplatin and vinoreblbine
- •- Previous history of cancer except basal cell cancer, carcinoma in situ of the cervix treaty or any other cancer treated by surgery alone or radiotherapy alone without extra-thoracic recurrence for 5 years
- •- Significant disease affecting the functioning of the gastrointestinal
- •- Patient enrolled into a clinical trial in last month
- •- Metastatic disease with bone marrow infiltration
- •- Superior vena cava syndrome
- •- Drain pleural effusion
- •- Lymphangitis carcinomatous
- •- Operable Lung Cancer
- •- Previous treatment for lung cancer: radiotherapy, chemotherapy, hormonal treatment, endobronchial desobstruction within the last week
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