Phase II Trial of Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC

Peking University People's Hospital1 site in 1 country50 target enrollmentJanuary 2013

ConditionsNon-small Cell Lung Cancer

Interventionsdocetaxel/cisplatin Radiation

Drugsdocetaxel/cisplatin

Overview

Phase: Phase 2
Intervention: docetaxel/cisplatin
Conditions: Non-small Cell Lung Cancer
Sponsor: Peking University People's Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: downstage rate of mediastinal lymph nodes
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

January 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University People's Hospital

Responsible Party

Principal Investigator

Jun Wang

Principal Investigator

Peking University People's Hospital

Eligibility Criteria

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
•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.