Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: docetaxel/cisplatin; Radiation: Radiation

• Registration Number: NCT01771289
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-18
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-25
• Last Update Posted: 2016-09-27
• Primary Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemoradiation	Radiation	-
chemoradiation	docetaxel/cisplatin	-

Primary Outcome Measures

Name	Time	Method
downstage rate of mediastinal lymph nodes	8 weeks

Secondary Outcome Measures

Name	Time	Method
overall survival	5y
Disease-free survival	5y
resection rate	12 weeks

Trial Locations

Locations (1)

Peking university people's hospital; 🇨🇳 Beijing, Beijing, China