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
Protocol serial number	LUN/INT
Sponsor	Northern and Yorkshire Clinical Trials and Research Unit (UK)
Funder	Northern & Yorkshire Clinical Trials and Research Unit (UK)

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

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	07/05/1997

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

31/10/2019: No publications found. All search options exhausted.
30/11/2015: No publications found in PubMed.