Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
03/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study 10

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Lung (small cell) cancer

Intervention

1. GC Arm: 3-weekly regimen (6 cycles) Gemcitabine 1200 mg/m(2) IV (Day 1 and 8) Carboplatin (AUC 5) Dose in mg calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day1)

2. PE Arm: 3-weekly regime (6 cycles): Cisplatin 60 mg/m2 IV Day 1 Etoposide 120 mg/m2 IV (Day 1) and 100 mg bd po (days 2 and 3)

Intervention type

Drug

Phase

Phase III

Drug names

Cancer drugs

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1996

Overall trial end date

31/10/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically proven small cell anaplastic carcinoma of the lung
2. Extensive stage disease or limited stage but locally advanced or limited stage with poor prognostic factors
3. Measurable or evaluable disease
4. Adequate renal function for chemotherapy
5. Age 18 years or above
6. Adequate contraception for women of child bearing potential
7. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1996

Recruitment end date

31/10/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

NCRI CSG and London Lung Cancer Group (UK)

Sponsor details

-
London
-
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

NCRI CSG and London Lung Cancer Group (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

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11510029

Publication citations

  1. Results

    Steele JP, Gemcitabine/carboplatin versus cisplatin/etoposide for patients with poor-prognosis small cell lung cancer: a phase III randomized trial with quality-of-life evaluation., Semin. Oncol., 2001, 28, 3 Suppl 10, 15-18.

Additional files

Editorial Notes