NCT00812266

Brief Summary

Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
281

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

7.9 years

First QC Date

December 19, 2008

Last Update Submit

January 23, 2016

Conditions

Extensive DiseaseFirst-LineSmall Cell Lung Cancer

Keywords

SCLCExtensive diseasetopotecan

Outcome Measures

Primary Outcomes (1)

  • 2 years survival

    2 years

Secondary Outcomes (1)

  • Response rates

    2 years

Study Arms (2)

A

EXPERIMENTAL

Topotecan + cisplatin

Drug: topotecan + cisplatin

B

ACTIVE COMPARATOR

Etoposide + carboplatin

Drug: Etoposide + carboplatin

Interventions

topotecan + cisplatinDRUG

topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W

A
Etoposide + carboplatinDRUG

Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed SCLC
  • Extensive stage
  • No prior chemotherapy
  • WHO PS 0-3
  • Adequate organ function (liver, kidney)
  • Adequate hematology (bone marrow)
  • Informed consent

You may not qualify if:

  • PS 4
  • Inadequate organ function
  • Uncontrolled infection
  • Concomitant major medical contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Oncology, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

TopotecanCisplatinEC regimen

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Seppo W Langer, MD PhD

    Dept. of Oncology, Rigshospitalet, Copenhagen

    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
MD pHD

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

January 1, 2006

Primary Completion

December 1, 2013

Study Completion

January 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

DK(1)