Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ernie Marshall

ORCID ID

Contact details

Clatterbridge Centre for Oncology
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
+44 0151 334 1155
ernie.marshall@ccotrust.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0067120650

Study information

Scientific title

Acronym

Study hypothesis

A randomised phase II study of carboplatin and vinorelbine versus carboplatin and etoposide in good performance status small cell lung cancer patients presenting with adverse prognostic factors.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cancer: Small cell lung cancer

Intervention

1. Chemotherapy with carboplatin and vinorelbine
2. Chemotherapy with carboplatin and etoposide

Added July 2008: trial stopped because of poor recruitment

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

1. Toxicity
2. Tumour response

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/04/2002

Overall trial end date

08/04/2006

Reason abandoned

Insufficient personel

Eligibility

Participant inclusion criteria

1. Elderly patients >65 years with good prognosis and Eastern Cooperative Oncology Group (ECOG) p/s <2
2. Confirmed small cell lung cancer not considered eligible for aggressive multimodality therapy

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

Total target recruitment = 80 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

08/04/2002

Recruitment end date

08/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clatterbridge Centre for Oncology
Wirral
CH63 4JY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Clatterbridge Centre for Oncology NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes