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ISRCTN
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ISRCTN73797340
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ClinicalTrials.gov identifier
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Public title
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A randomised study of oral versus intravenous chemotherapy in poor prognosis 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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TR9SCLC
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Study hypothesis
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Not provided at time of registration
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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 (small cell)
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Participants - inclusion criteria
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1. Histologically or cytologically proven SCLC
2. Patients with extensive disease and poor prognosis, ie Eastern Cooperative Oncology Group (ECOG) performance 2 or 3 or alkaline phosphatase >1.5 upper limit normal range
3. Patients 75 years and over, whatever stage of disease, deemed fit for randomisation
4. No previous malignancy, except non melanomatous skin cancer in the preceding 3 years
5. No medical contraindications to treatment
6. Adequate renal function
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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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01/01/1997
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Anticipated end date
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31/12/2000
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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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Not provided at time of registration
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Interventions
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1. Regimen A: Chemotherapy, oral etoposide repeated every 3 weeks for six courses.
2. Regimen B: Multi-drug chemotherapy, CAV (cyclophosphamide, adriamycin, vincristine) alternating every 3 weeks with PE (etoposide, cisplatin). A total of six courses, three with each drug combination.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Not available
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
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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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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UK Co-ordinating Committee for Cancer Research (UKCCCR)
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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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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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Date applied
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01/07/2001
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Last edited
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13/05/2008
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Date ISRCTN assigned
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01/07/2001
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