Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LUN/INT
Study information
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
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1997
Overall trial end date
07/05/1997
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/1997
Recruitment end date
07/05/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Northern and Yorkshire Clinical Trials and Research Unit (UK)
Sponsor details
17 Springfield Mount
Leeds
LS2 9NG
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Northern & Yorkshire Clinical Trials and Research Unit (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary