| Source of record | UK Trials |
| ISRCTN | ISRCTN46536242 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | LU11 |
| Public title | Post-Operative Radiotherapy for Non-Small Cell Lung Cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lung (non-small cell) cancer |
| Study hypothesis | Not provided at time of registration.
|
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Either sex, aged 75 years or less
2. World Health Organisation (WHO) performance status zero to two
3. Lung and cardiac function adequate for proposed resection
4. No previous specific anti-cancer treatment for current disease
5. No other malignant disease, except basal cell carcinoma or in situ carcinoma of the cervix
6. pT1 pN1 M0, pT2 pN1 M0, pT1 pN2 M0 or pT2 pN2 M0 non-small cell lung cancer
7. No other serious condition contraindicating surgery or radiotherapy
8. Complete resection of non-small cell lung cancer |
| Participants - exclusion criteria | Not provided at time of registration.
|
| Patient information material |
|
| Anticipated start date | 01/01/2002 |
| Anticipated end date | 31/12/2002 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | Patients are randomised two to four weeks postoperatively to either:
1. Schedule R: Radiotherapy 40 Gy given in daily fractions five days a week over three weeks to mediastinum starting four to six weeks post-operatively.
2. Schedule NoR: No further specific treatment including post-operative radiotherapy unless or until the disease recurrence. |
| Primary outcome measure(s) | Not provided at time of registration.
|
| Secondary outcome measure(s) | Not provided at time of registration.
|
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.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 | ISRCTN46536242 |
| Date last extracted from ISRCTN register | 17/04/2008 |
