Condition category
Cancer
Date applied
13/03/2001
Date assigned
13/03/2001
Last edited
14/09/2009
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 Danielle Andrews

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LU19

Study information

Scientific title

Acronym

Study hypothesis

The aim of the trial is to investigate in patients with limited or extensive SCLC and good performance status, whether the addition of haemopoeitic growth factor (G-CSF) to chemotherapy:
1. Improves survival
2. Permits shortening of the interval between cycles
3. Reduces toxic myelosuppression
4. Affects the quality of life during the first 6 months from randomisation

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 cancer

Intervention

The trial is designed to determine whether dose intensification with G-CSF is associated with a significant improvement in outcome compared with SCLC patients not receiving G-CSF. Patients with limited or extensive SCLC and a performance status of WHO 0-2 are randomised to receive ACE chemotherapy with or without G-CSF.

Intervention type

Drug

Phase

Not Specified

Drug names

Haemopoeitic growth factor (G-CSF)

Primary outcome measures

Principle end-point is survival from randomisation

Secondary outcome measures

Secondary end-points are:
1. Interval between cycles of chemotherapy
2. Clinical septicaemic myelosuppression
3. WHO grade 3 or 4 neutropenia (less than 1000/mm3 cubed) 2 weeks after the first 3 cycles of chemotherapy
4. Quality of life
5. Days spent in hospital

Overall trial start date

01/12/1993

Overall trial end date

01/03/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Untreated, microscopically proven SCLC
2. World Health Organisation (WHO) performance status 0-2
3. Alkaline phosphatase (AP) and Alanine amino transferase (ALT) less than or equal to 2.5 x upper normal limit and serum creatine/urea less than or equal to 1.25 x upper normal limit
4. Not receiving any other investigational drugs
5. Female patients must not be pregnant

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

400

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/1993

Recruitment end date

01/03/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Analysis of messy longitudinal data from a randomized clinical trial. MRC Lung Cancer Working Party (2000) in http://www.ncbi.nlm.nih.gov/pubmed/10986540

Publication citations

  1. Qian W, Parmar MK, Sambrook RJ, Fayers PM, Girling DJ, Stephens RJ, Analysis of messy longitudinal data from a randomized clinical trial. MRC Lung Cancer Working Party., Stat Med, 2000, 19, 19, 2657-2674.

Additional files

Editorial Notes