Condition category
Cancer
Date applied
15/10/2002
Date assigned
15/10/2002
Last edited
15/12/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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 measures

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

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

http://www.ed.ac.uk

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22672970

Publication citations

Additional files

Editorial Notes