A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low-risk for recurrence: NVALT-8A - NVALT-8A

MCG0 个研究点开始时间: 2009年7月6日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Age = 18 years
•-Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1
•-SUVmax < 7
•-Patients with NSCLC who had a surgical R0 resection.
•-Performance score = 2 before chemotherapy.
•-Adequate organ function before administration of chemotherapy, including:
•Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
•Hepatic: bilirubin < 1.5 x ULN, AP, ALT, AST < 3.0 x ULN.
•Renal: calculated creatinine clearance > 60 ml/min based on the Cockroft and Gault formula.
•-Patients must sign and date a written Independent Ethics Committee approved informed consent form.
•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

•-Patients with incomplete or inadequate pulmonary resections. incomplete preoperative or intraoperative staging, wedge or segmental resection.
•-Prior chemotherapy or radical radiotherapy.
•-Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
•-Concomitant treatment with any other experimental drug under investigation.
•-History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, except non-melanoma skin cancer or in situ cervical cancer.
•-Pregnancy
•-Women of child-bearing potential not using effective means of contraception

发起方

MCG