| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN61727489 |
| Date ISRCTN assigned | 15/10/2002 |
| Local reference number(s) | GRIN |
| Public 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 (NSCLC) |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lung (non-small cell) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| 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 radiotherapy) plus radiotherapy |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Educational grant from Lilly Oncology to University of Edinburgh |
| Sponsor name | University of Edinburgh |
| Sponsor details | The University of Edinburgh
Old College
South Bridge
Edinburgh
United Kingdom
EH8 9YL |
| Sponsor telephone | +44 (0)131 650 1000 |
| Sponsor fax | +44 (0)131 650 2147 |
| Sponsor email | communications.office@ed.ac.uk |
| Sponsor website | http://www.ed.ac.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN61727489 |
| Date last extracted from ISRCTN register | 17/04/2008 |
