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Trial Title:
Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
NCT ID:
NCT01771289
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Conditions: Keywords:
Lung Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
docetaxel/cisplatin
Description:
weekly docetaxel/cisplatin combined with radiation
Arm group label:
chemoradiation
Intervention type:
Radiation
Intervention name:
Radiation
Description:
chemoradiation
Arm group label:
chemoradiation
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking university people's hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Fan Yang
Phone:
+8688326657
Email:
dr.yangf@gmail.com
Start date:
January 2013
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01771289
