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ISRCTN
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ISRCTN61727489
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ClinicalTrials.gov identifier
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Public title
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A Phase III study of Radical Radiotherapy with or without Gemcitabine in Patients with T1-2 N0-1 M0 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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GRIN
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Study hypothesis
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Not provided at time of registration
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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 (non-small cell) cancer
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Participants - inclusion criteria
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1. Histological or cytological diagnosis of T1-2 N0-1 M0 NSCLC in patients deemed unfit for resection in the opinion of the thoracic surgeon
2. No prior chemotherapy or radiotherapy for the treatment of NSCLC
3. Performance status 0-2 on the Zubrod scale 4. Estimated life expectance at least 12 weeks
5. <10% weight loss in the year preceding randomisation
6. Patient compliance and geographic proximity allowing adequate follow-up
7. Adequate bone marrow reserve
8. Adequate respiratory function
9. Radiologically measurable or non-measurable lesion
10. Aged at least 18 years
11. Written informed consent
12. Effective contraception (where appropriate) during and for at least 3 months following the trial
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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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01/01/2003
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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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Patients will be randomised to:
1. Radiotherapy (55 Gy 2.75 Gy 5 days/week over 4 weeks OR 60 Gy over 6 weeks with daily fractions of 2 Gy)
2. Gemcitabine (100 mg/m2 IV over 30 min, 2-4 h prior to radiotherapy) plus radiotherapy
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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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Educational grant from Lilly Oncology to University of Edinburgh (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) 207 670 4723
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Fax
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+44 (0) 207 670 4818
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Email
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Sponsor
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University of Edinburgh
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Address
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The University of Edinburgh
Old College
South Bridge
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City/town
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Edinburgh
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Zip/Postcode
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EH8 9YL
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Country
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United Kingdom
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Tel
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+44 (0)131 650 1000
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Fax
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+44 (0)131 650 2147
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Email
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communications.office@ed.ac.uk
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Sponsor website:
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http://www.ed.ac.uk
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Date applied
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15/10/2002
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Last edited
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02/03/2011
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Date ISRCTN assigned
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15/10/2002
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