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

Phase 3

Completed

• Conditions: Carcinoma, Small Cell
• Interventions: Drug: Belotecan; Drug: Etoposide; Drug: Cisplatin

• Registration Number: NCT00826644
• Lead Sponsor: Chonnam National University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• ECOG Performance status 0~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
• Histologically or cytologically confirmed small cell lung cancer Patient without chemotherapy and radiotherapy
• Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
• Life expectancy of at least 3 months
• Provision of written informed consent

Exclusion Criteria

• As judged by the investigator, any evidence of severe or uncontrolled systemic disease
• Serum bilirubin greater than 3 times the upper limit of reference range(ULRR)
• Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of liver metastases)
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
• Pregnancy or breast-feeding women(women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
• Evidence of brain metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Belotecan plus Cisplatin	Belotecan	-
Belotecan plus Cisplatin	Cisplatin	-
Etoposide plus Cisplatin	Cisplatin	-
Etoposide plus Cisplatin	Etoposide	-

Primary Outcome Measures

Name	Time	Method
To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer	two years

Secondary Outcome Measures

Name	Time	Method
to assess the overall survival	two years
To assess the time to progression	two years
to assess the overall response duration	two years

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Korea, Republic of