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
| ISRCTN | ISRCTN66281665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66281665 |
| Secondary identifying numbers | LUN/INT |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 31/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific 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 |
| 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 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). |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1997 |
| Completion date | 07/05/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 07/05/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Northern and Yorkshire Clinical Trials and Research Unit (UK)
Research organisation
Research organisation
17 Springfield Mount
Leeds
LS2 9NG
United Kingdom
| Website | http://www.leeds.ac.uk/medicine/nyctru/nyctru_page1.htm |
|---|
Funders
Funder type
Research organisation
Northern & Yorkshire Clinical Trials and Research Unit (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
31/10/2019: No publications found. All search options exhausted.
30/11/2015: No publications found in PubMed.
