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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61727489

Enrollment

Unknown

Registered

2002-10-15

Start date

2003-01-01

Completion date

Unknown

Last updated

2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung (non-small cell) cancer Cancer Lung (non-small cell) cancer

Interventions

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 ra

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Not provided at time of registration	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026