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ISRCTN
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ISRCTN57155593
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ClinicalTrials.gov identifier
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Public title
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The Big Lung Trial: Does Short-Term Chemotherapy Improve the Survival of Patients with Non-Small Cell Lung Cancer (NSCLC)
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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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BLT
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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 (non-small cell)
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Participants - inclusion criteria
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1. Fulfil local criteria for diagnosis of NSCLC
2. Be fit to receive, and have no clear contraindications to chemotherapy
3. Patients randomised to adjuvant chemotherapy should be able to start chemotherapy within 10 weeks of completion of surgery or radical radiotherapy
4. No concurrent malignancy, or any history of malignancy, other than non-melanomatous skin cancer within the last 3 years
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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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01/01/1995
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Anticipated end date
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31/12/2005
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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. CHEMOTHERAPY REGIMEN: Three cycles of one of the following regimens should be given: Cisplatin plus vindesine; Mitomycin C, ifosfamide and cisplatin; Mitomycin C, vinblastine and cisplatin; Navelbine and Cisplatin.
Chemotherapy may be given as follows:
A. Adjuvant Chemotherapy Option: Chemotherapy to start as soon as possible after surgery or following completion of radical radiotherapy.
B. Neo-adjuvant Option: Chemotherapy should start as soon as possible.
C. Supportive Care Group: Chemotherapy should start as soon as possible after randomisation and be given concurrently with supportive care.
2. CONTROL REGIMEN: No chemotherapy.
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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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NHS Research and Development Programme (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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NHS R&D 'Time-Limited' National Programmes
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Address
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Commissioning Units
Canynge Hall
Whiteladies Road
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City/town
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Bristol
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Zip/Postcode
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BS8 2PR
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Country
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United Kingdom
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Date applied
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19/08/2002
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Last edited
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13/05/2008
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Date ISRCTN assigned
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19/08/2002
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