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ISRCTN
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ISRCTN26181691
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ClinicalTrials.gov identifier
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Public title
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Weekly intensive versus standard chemotherapy in untreated small cell lung cancer (SCLC) patients with good prognosis
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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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TR6SCLC
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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. Age 75 or under
3. Either limited disease or extensive disease in the good prognostic category. That is have both of the following characteristics, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and alkaline phosphatase <1.5 upper limit of normal range
4. Adequate renal function
5. No previous malignancy, except non-melanomatous skin cancer
6. No previous chemotherapy or radiotherapy
7. No medical contraindications to treatment
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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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01/01/1988
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Anticipated end date
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31/12/1992
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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. Intensive Regimen: Chemotherapy, cisplatin and etoposide alternating every 7 days with ifosfamide and adriamycin. A total of twelve courses, six with each drug combination.
2. Standard Regimen: Chemotherapy, cisplatin and etoposide alternating every 21 days with ifosfamide and adriamycin. A total of six courses, three with each drug combination.
All limited disease patients who show complete or partial response following chemotherapy receive thoracic irradiation.
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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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Cancer Research UK
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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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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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30/01/2008
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Date ISRCTN assigned
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01/07/2001
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