| Source of record | UK Trials |
| ISRCTN | ISRCTN66281665 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | LUN/INT |
| Public title | A phase II randomised trial to assess external beam radiotherapy and intraluminal bronchial brachytherapy as re-treatment in patients with lung cancer who have received primary palliative external beam therapy |
| Scientific title |
|
| Acronym | Not Applicable |
| 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. Histologically confirmed non-small cell cancer
2. Respiratory symptoms due to lung cancer
3. Previous palliative external beam radiotherapy
4. Expected survival at least two months
5. When patient requires retreatment, radiotherapist considers suitability for further course of external beam radiotherapy or intraluminal bronchial brachytherapy
6. Well enough to tolerate fibre optic bronchoscopy: at bronchoscopy patient has endobronchial disease and it is still considered that the patient could be treated with intraluminal bronchial brachytherapy |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1997 |
| Anticipated end date | 07/05/1997 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients with respiratory symptoms requiring re-treatment after palliative external beam radiotherapy are randomised to one of two regimens:
1. External Beam Radiotherapy:
Patients will be treated by the radiotherapist using whatever schedule is thought appropriate. There will be no standardisation of treatment although 20 Gy in five fractions over five to seven days, with appropriate attention to shielding of the spinal cord, where indicated, is recommended.
2. Intraluminal Bronchial Brachytherapy:
Intraluminal Bronchial Brachytherapy 10 Gy at 1 cm. To be carried out as a day case procedure at Cookbridge Hospital, Leeds using fibre-optic bronchoscopy and standard published protocol (Goldman et al, 1993). |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Northern & Yorkshire Clinical Trials and Research Unit (UK) |
| Sponsor name | Northern and Yorkshire Clinical Trials and Research Unit (UK) |
| Sponsor details | 17 Springfield Mount
Leeds
United Kingdom
LS2 9NG |
| Sponsor website | http://www.leeds.ac.uk/medicine/nyctru/nyctru_page1.htm |
| 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 | ISRCTN66281665 |
| Date last extracted from ISRCTN register | 17/04/2008 |
