Clinical trial NCT01771289: Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
Official title: Phase II Trial of Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Lung Cancer
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: downstage rate of mediastinal lymph nodes
timeFrame: 8 weeks
Secondary outcomes:
measure: overall survival
timeFrame: 5y
measure: Disease-free survival
timeFrame: 5y
measure: resection rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university people's hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: