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

NCT00826644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2021-08-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    collaborator INDUSTRY

  • Chonnam National University Hospital

    lead OTHER

Principal Investigators

  • In-Jae Oh, M.D.,Ph.D. · Chonnam National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00826644 on ClinicalTrials.gov