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

Phase 3

Completed

• Conditions: ung (non-small cell) cancer; Cancer; Lung (non-small cell) cancer

• Registration Number: ISRCTN61727489
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-10-15
• Study Completion: 2005-12-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 0

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

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration