Trials Sponsors Conditions Drugs Pricing

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

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

Sponsors & Collaborators

Chong Kun Dang Pharmaceutical
Industrycollaborator
Chonnam National University Hospital
Otherlead

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

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 Neoplasms

Study Officials

In-Jae Oh, M.D.,Ph.D.
Chonnam National University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

147 participants (actual enrollment reported by the registry).

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 2009

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Belotecan plus Cisplatin

Etoposide plus Cisplatin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Belotecan plus Cisplatin

Etoposide plus Cisplatin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations