Status:
COMPLETED
Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Gyeongsang National University Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The rationale of phase II study of biweekly docetaxel and cisplatin in patients with unresectable NSCLC are follows: First, the optimal dose and schedule of combination with docetaxel and cisplatin a...
Detailed Description
Study design is followings: The sample size was calculated according to Simon's two stage optimal design. Assuming a response rate of 40%, a probability of error of 5% and a power of 80%, a total of 4...
Eligibility Criteria
Inclusion
- patients who were≥ 65 years of age and they had an Easten Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, or the patients who were \< 65 years of age and they had an ECOG PS 2
- histologically confirmed non-small cell carcinoma
- stages IIIB-IV disease
- adequate hematologic parameters (hemoglobin concentration of at least 9.0 g/dL, absolute neutrophil count ≥1,500/mm3, and platelet count ≥100,000/mm3), renal function (serum creatinine ≤1.5 mg/dL), and liver function (total bilirubin ≤1.5 mg/dL and serum transaminase level less than twice the upper limit of normal)
- at least one bi-dimensionally measurable lesion, according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Exclusion
- Active infection
- Prior chemotherapy, radiotherapy or surgery for their disease,
- A history of myocardial infarction in the last 3 months before entry to the study
- Uncontrolled congestive heart failure or hypertension
- Uncontrolled diabetes mellitus, pregnancy, lactation or a prior second primary cancer except for cervix cancer in situ or skin cancer
- All the patients provided written informed consent before they entered the study
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00995761
Start Date
October 1 2009
End Date
August 1 2012
Last Update
March 3 2014
Active Locations (1)
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1
Gyeongsang National University Hospital
Jinju, Gyeongsang-Nam-Do, South Korea, 660-702