Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GRIN
Study information
Scientific title
A Phase III study of radical radiotherapy with or without gemcitabine in patients with T1-2 N0-1 M0 non-small cell lung cancer
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lung (non-small cell) cancer
Intervention
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
Intervention type
Drug
Phase
Phase III
Drug names
Gemcitabine
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2003
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
University of Edinburgh (UK)
Sponsor details
The University of Edinburgh
Old College
South Bridge
Edinburgh
EH8 9YL
United Kingdom
+44 (0)131 650 1000
communications.office@ed.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Educational grant from Lilly Oncology to University of Edinburgh (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22672970