Induction chemotherapy with docetaxel and cisplatin followed by radiotherapy concomitant with cetuximab for locally advanced stage III non-small cell lung cancer- amulticentre, open label non-randomised phase II trial - Satellit

Sahlgrenska University Hospital0 个研究点目标入组 75 人开始时间: 2005年11月24日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•·Histological or cytological diagnosis of a NSCLC Stage IIIA/IIIB
•Non- resectable or medically inoperable patients.
•Received no prior chemotherapy or radiation therapy for NSCLC
•PS WHO 0 - 1.
•FEV1 ³ 1L or ³ 40% of expected volume.
•Adequate bone marrow reserve: WBCC ³ 3.0 ´ 109/L, Platelets ³100 ´ 109/L, Haemoglobin ³100 ml/l .·
•Age ³18 years, no upper age limit.
•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

•Evidence of active infection at the discretion of the investigator.·
•Inadequate liver function: Bilirubin >1,5 x UNL, ALAT or ASAT >3,0 UNL·
•Inadequate kidney function: creatinine >1,5 x UNL or GFR < 50 ml/min.·Pleural effusion with positive cytology·
•Serious concomitant systemic disorder incompatible with the study.·Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 5 years.

发起方

Sahlgrenska University Hospital