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 |
| Protocol serial number | GRIN |
| Sponsor | University of Edinburgh (UK) |
| Funder | Educational grant from Lilly Oncology to University of Edinburgh (UK) |
- Submission date
- 15/10/2002
- Registration date
- 15/10/2002
- Last edited
- 18/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Gemcitabine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
