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ISRCTN
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ISRCTN52253218
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ClinicalTrials.gov identifier
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Public title
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A Phase III randomised comparison of Gemcitabine/Carboplatin with Mitomycin, Ifosfamide and Cisplatin in non-small cell lung cancer
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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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Study 11
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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) cancer
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Participants - inclusion criteria
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1. Histologically or cytologically proven non-small cell carcinoma of the lung
2. Stage IIIb or IV disease
3. Measurable or evaluable disease
4. Adequate renal function (Ethylene diamine tetraacetic acid [EDTA] Clearance >60 ml/min)
5. Age 18 or over
6. Adequate contraception in females of child-bearing potential
7. Written informed consent
8. No prior radiotherapy or chemotherapy
9. Not less than 8 weeks life expectancy
10. No history of prior malignancy (except non-melanomatous skin tumour or has been without evidence of disease for 3 years or more)
11. White cell count >3000/ml Platelet count >100,000/ml Haemaglobin >10.0 g.dL
12. No symptomatic brain metastases
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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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31/08/2001
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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. GC Arm: 3-weekly regimen. Gemcitabine 1200 mg/m2 IV (Day 1 and 8) Carboplatin (AUC 5). Dose calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day 1)
2. MIC 3-Weekly regimen: Mitomycin 6 mg/m2 IV (Day 1) Ifosfamide 3 g/m2 IV (Day 1) Cisplatin 50 mg/m2 IV (Day 1)
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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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London Lung Cancer Group (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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London Lung Cancer Group (UK)
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Address
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-
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City/town
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London
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Zip/Postcode
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-
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Country
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United Kingdom
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Email
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Date applied
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19/08/2002
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Last edited
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14/01/2009
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Date ISRCTN assigned
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19/08/2002
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