A Randomised Trial Comparing External Beam Radiotherapy Alone With External Beam Radiotherapy Plus Intraluminal Irradiation for Palliation in Lung Cancer

ISRCTN	ISRCTN83218866
DOI	https://doi.org/10.1186/ISRCTN83218866
Protocol serial number	ILT-2
Sponsor	UK Co-ordinating Committee for Cancer Research (UKCCCR)
Funder	Cancer organisations (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

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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
Scientific title	A Randomised Trial Comparing External Beam Radiotherapy Alone With External Beam Radiotherapy Plus Intraluminal Irradiation for Palliation in Lung Cancer
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	1. Schedule A: External beam radiotherapy, a maximum subcutaneous dose of 3250 cGy given in eight fractions over 10 days with a margin of 2 cm around the tumour. 2. Schedule B: External beam radiotherapy, a maximum subcutaneous dose of 3250 cGy given in eight fractions over 10 days with a margin of 2 cm around the tumour. Followed by intraluminal radiotherapy, a single dose of 1500 cGy to be given on the last day of external beam radiotherapy.
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	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Key inclusion criteria	1. Biopsy proven non-small cell lung cancer 2. Fit to receive bronchoscopy 3. Fit to receive external beam radiotherapy 4. Any age 5. Shortness of breath, cough, haemoptysis, dysphagia or chest pain resulting from a primary bronchial tumour 6. No previous or concomitant malignancy, except basal cell carcinomas 7. No symptomatic metastases requiring external beam radiotherapy 8. No previous chest irradiation for lung cancer 9. No bilateral lung tumours or tracheal tumours
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2005

MRC Clinical Trials Unit

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