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ISRCTN
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ISRCTN15921116
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DOI
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10.1186/ISRCTN15921116
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised controlled dose intensification clinical trial of chemotherapy with or without recombinant human granulocyte colony stimulating factor (G-CSF) in small cell lung cancer (SCLC)
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Scientific title
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Acronym
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N/A
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Serial number at source
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LU19
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lung cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/12/1993
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Anticipated end date
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01/03/1996
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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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.
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Primary outcome measure(s)
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Principle end-point is survival from randomisation
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Secondary outcome measure(s)
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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
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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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
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Contact name
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Dr
Danielle
Andrews
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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13/03/2001
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Last edited
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14/09/2009
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Date ISRCTN assigned
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13/03/2001
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