Weekly Versus 3-Weekly Docetaxel Plus Cisplatin for Advanced NSCLC
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT00319514
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.
- Detailed Description
The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated with a significant incidence of severe neutropenia, often complicated by fever. Therefore, there has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. We designed this randomized phase II trial to evaluate the safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin given as first-line therapy in patients with advanced NSCLC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- histologically or cytologically proven non-small cell lung cancer
- no prior chemotherapy or only adjuvant chemotherapy which had been completed >6 months before registration
- ECOG performance status 0 to 2
- measurable lesion(s)
- normal marrow, hepatic and renal functions
- provision of written informed consent
- active infection or severe comorbidities
- history of anaphylaxis of any origin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival Overall survival Safety
Trial Locations
- Locations (1)
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of