NCT00826644

Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient

A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer. Primary endpoints * to assess Response Rate Secondary endpoints * to assess Overall response duration, Time to progression, Overall survival

Conditions

• Carcinoma, Small Cell

Interventions

Type	Name	Description
DRUG	Belotecan	Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks
DRUG	Etoposide	Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks
DRUG	Cisplatin	Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2009-01-22
• Last updated: 2021-08-09

Locations

1 site across 1 country: South Korea