EUCTR2015-003312-21-ES进行中（未招募）1 期
Phase II clinical trial with tri-weekly metronomic oral vinorelbine and cisplatin as induction treatment for and subsequent concomitant with radiotherapy (RT) in patients with non small cell lung cancer (NSCLC) locally advanced unresectable.
Grupo Español de Cáncer de Pulmón0 个研究点目标入组 67 人开始时间: 2015年12月10日最近更新:
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
- 67
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
入选标准
- •-Patients with confirmed histologic diagnosis of NSCLC?s in stage IIIA and IIIB unresectables.
- •-Realization of a basal PET-CT that dismisses the presence of distant disease and confirm that it is a NSCLC not candidate to radical surgery treatment. The positive mediastinal lymph nodes for PET-CT have to be confirmed histologically. It could be considered affected mediastinic lymph nodes without necessity of verify histologically, when there is a mass at the lymph nodes area without distinguished edges.
- •-Disease measurable by CT, as minimum one lesion.
- •-Performance status ECOG 0-1.
- •-Life expectation > 12 weeks.
- •-Age ?18 years and ? 75 years.
- •-Satisfactory renal function: creatinine ? 1.5 mg/dl or creatinine clearance > 60 ml/min.
- •-Correct hematological function: Hemoglobin > 10 g/dl, neutrophils ? 1500, platelets ? 100000.
- •-Correct liver function: bilirubin ? 1.5 times the maximum limit of the normality, transaminases ? 2.5 over the upper limit of the normality.
- •-Correct lung function: defined by forced expired volume in 1 second (FEV1) >50% of normal volume, and lung diffusing capacity for carbon monoxide (DLCO) > 40% of normal value.
- •-Lung normal proportion exposed to >20 Gy of RT (V20) have to be ? 35%.
- •-Informed consent signature
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •-Decrease in weight > 5% in the last 3 months previous to the study entry.
- •-Intestinal problems that do not ensure a correct absorption of oral vinorelbine.
- •-Pregnant and lactating women. Women in childbearing age should have a negative pregnancy test, men and women under this condition should use contraceptive measures during all the clinical trial.
- •-Symptomatic sensory neuropathy > grade 1 according with the toxicity criteria of CTCAE v4.
- •-Non-controlled comorbidities.
- •-Superior vena cava syndrome.
- •-Pleural or pericardial effusion: both will be considered as metastatic disease indicators unless will be demonstrated the opposite. These that have a negative cytological for malignancy, being exudate, will be excluded too. These patients with non-visible pleural effusion in thoracic radiology or so small for realize a safe diagnostic puncture can be included.
- •-Known hypersensitivity to drugs with similar structure of the study drugs.
- •-Previous treatment with antineoplastic drugs or previous thoracic radiotherapy for the lung cancer or for other reason. Previous surgery for the lung cancer.
- •-Personal background of other neoplasia, except cervical or breast carcinoma in situ and the skin basal cell carcinoma, treated in the correct way in a period of less than 5 years.
- •-Concomitant treatment with any other antineoplastic medicine or in investigation study.
- •- Patients in any psychological situation, familiar, sociological or geographical that can complicate the correct accomplishment of the study protocol and the following-up program
研究者
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