NCT00826644

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

4.1 years

First QC Date

January 21, 2009

Last Update Submit

August 2, 2021

Conditions

Carcinoma, Small Cell

Keywords

Small cell lung cancerCamptothecinResponse rate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • to assess the overall response duration

    two years

  • To assess the time to progression

    two years

  • to assess the overall survival

    two years

Study Arms (2)

Belotecan plus Cisplatin

EXPERIMENTAL
Drug: BelotecanDrug: Cisplatin

Etoposide plus Cisplatin

ACTIVE COMPARATOR
Drug: EtoposideDrug: Cisplatin

Interventions

BelotecanDRUG

Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks

Also known as: Camtobell
Belotecan plus Cisplatin
EtoposideDRUG

Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks

Etoposide plus Cisplatin
CisplatinDRUG

Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks

Belotecan plus CisplatinEtoposide plus Cisplatin

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

Location

Related Publications (1)

  • Oh IJ, Kim KS, Park CK, Kim YC, Lee KH, Jeong JH, Kim SY, Lee JE, Shin KC, Jang TW, Lee HK, Lee KY, Lee SY. Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial. BMC Cancer. 2016 Aug 26;16(1):690. doi: 10.1186/s12885-016-2741-z.

    PMID: 27566413DERIVED

MeSH Terms

Conditions

Carcinoma, Small CellSmall Cell Lung Carcinoma

Interventions

belotecanEtoposideCisplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • In-Jae Oh, M.D.,Ph.D.

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)