Gene expression as predictive markers of outcome in non-small cell lung cancer patients (stage IIIB with pleural effusion and stage IV) treated with chemotherapy. Phase II trial of GOIRC. - ND

GRUPPO ONCOLOGICO ITALIANO DI RICERCA0 个研究点开始时间: 2010年11月2日最近更新: 2012年4月3日

适应症

试验速览

暂无简介。

•Histological or cytological confirmation of NSCLC Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Stage IIIB/IV) Samples for genetic research Age ≥ 18 years old and ≤ 72 or older ECOG PS 0-1 Measurable (uni-dimensional) disease by RECIST criteria in a lesion not previously irradiated or non-measurable disease Absolute neutrophil count greater than 1.5 x 109/L, platelet count greater than 100 x 109/L and haemoglobin greater than 10 g/dl Bilirubin level either normal or <1.5 x ULN, AST (SGOT) and ALT (SGPT) <2.5 x ULN Serum creatinine <1.5 x ULN or creatinine clearance >60 ml/min Provision of written informed consent Effective contraception for both, male and female pts, if the risk of conception exists
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•No prior chemotherapy regimens Radiotherapy within 2 weeks of study entry or about target lesion Current infection Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease) Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study Positive pregnancy test

发起方

GRUPPO ONCOLOGICO ITALIANO DI RICERCA