| Source of record | UK Trials |
| ISRCTN | ISRCTN53968814 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | LU13 |
| Public title | Medical Research Council fourth non-small cell lung cancer radiotherapy study: clinical trial of radiotherapy for good-performance-status patients with inoperable non-small cell lung cancer too large in volume for radical radiotherapy |
| 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 | Not provided at time of registration.
|
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Primarily untreated, microscopically confirmed non-small cell lung cancer
2. Performance status World Health Organisation (WHO) grade zero to two
3. No previous surgery, radiotherapy or chemotherapy for non-small cell lung cancer
4. No other previous concomitant malignant disease. Except previous basal cell carcinoma or in situ carcinoma of the cervix
5. Disease too advanced for radical radiotherapy
6. No evidence of distant metastases outside of the locoregional volume
7. Either sex, any age |
| 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 | 1. Radiotherapy Regimen A: A total dose of 17 Gy given as two fractions of 8.5 Gy with an interval of one week between the fractions.
2. Radiotherapy Regimen B: A total dose of 39 Gy given as thirteen fractions of 3 Gy during three weeks in daily fractions five days per week.
Radiotherapy should start within two weeks of randomisation. If the patient has superior vena cava obstruction, a course of steroids may be given during the period of radiotherapy. |
| 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 | ISRCTN53968814 |
| Date last extracted from ISRCTN register | 17/04/2008 |
