A Phase III study of radical radiotherapy with or without gemcitabine in patients with T1-2 N0-1 M0 non-small cell lung cancer

ISRCTN	ISRCTN61727489
DOI	https://doi.org/10.1186/ISRCTN61727489
Secondary identifying numbers	GRIN

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Gemcitabine
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2003
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2003
Date of final enrolment	31/12/2005

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

University of Edinburgh (UK)
University/education

The University of Edinburgh
Old College
South Bridge
Edinburgh
EH8 9YL
Scotland
United Kingdom

Phone	+44 (0)131 650 1000
Email	communications.office@ed.ac.uk
Website	http://www.ed.ac.uk
"ROR"	https://ror.org/01nrxwf90

Industry

Educational grant from Lilly Oncology to University of Edinburgh (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/09/2012		Yes	No

18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)