Phase II Trial of Dose-Dense Paclitaxel and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Stage II and IIIA Non-Small Cell Lung Cancer - not available

CECOG0 个研究点目标入组 50 人开始时间: 2004年10月18日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•[1]Histologic or cytologic diagnosis of NSCLC (any subtype).
•[2]Presence of clinical Stage IIA, IIB or IIIA (T3 N1) disease, according to the revision by Mountain CF of American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997)
•[3]Tumor amenable to curative surgical resection.
•[4]Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to criteria defined in 3.8.12.
•[5]No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular target therapy, or any other type of tumor therapy).
•[6]Performance status of 0-1 on ECOG scale
•[9]Adequate organ function including the following:
•Adequate bone marrow reserve: White blood cells (WBC) ³3.0 ´ 109/L, absolute neutrophil (segmented and bands) count (ANC) ³1.5 ´ 109/L, platelets ³100 ´ 109/L and hemoglobin ³10 g/dL.
•Hepatic: bilirubin £1.0 x upper limit of normal (ULN), ALT and AST £2.5 x ULN, alkaline phosphatase £1.0 x ULN, Calcium £1.2 times the ULN
•Renal: creatinine £1.5 x ULN and calculated/measured creatinine clearance >50 ml/min (Cockcroft-Gault formula, See Protocol Attachment 3).
•[11]Males and females, age ³18 to 65 years.
•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) no
•F.1.3.1 Number of subjects for this age range

•[13]Presence of clinical Stage IIIA (T3 N2) disease, according to the revision by Mountain CF of American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997)
•[14]Treatment within the last 30 days with any investigational drug.
•[15]Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
•[16]Active infection that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy.
•[17]Pregnancy.
•[18]Breast feeding.
•[19]Serious concomitant disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator.
•[20]Poorly controlled diabetes mellitus.
•[21]Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
•[22]History of significant neurological or mental disorder, including seizures or dementia

发起方

CECOG