Non-small Cell Lung Cancer
Conditions
Keywords
Lung Cancer
Brief summary
The purpose of this study was to evaluate the safety and efficacy of neoadjuvant concurrent chemoradiation with weekly docetaxel/cisplatin in patients with resectable IIIA-N2 NSCLC.
Interventions
weekly docetaxel/cisplatin combined with radiation
RADIATIONRadiation
chemoradiation
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years older. * Present with histologically proven or cytological diagnosis of NSCLC Stage IIIA as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is amenable to surgery. * No prior systemic chemotherapy or targeted therapy for lung cancer before screening. * ECOG performance status of 0 or 1. * Life expectancy ≥12 weeks. * Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level). * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases. * Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min. * Female subjects should not be pregnant or breast-feeding.
Exclusion criteria
* Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). * Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy). * History of another malignancy in the last 5 years with the exception of the following:Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted. * Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * Known hypersensitivity to Tarceva or gemcitabine or cisplatin. * Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this. * Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| downstage rate of mediastinal lymph nodes | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 5y |
| Disease-free survival | 5y |
| resection rate | 12 weeks |
Countries
China
Contacts
Primary ContactJun Wang, MD
Backup ContactFan Yang, MD
Outcome results
None listed