Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LU13
Study information
Scientific title
Medical Research Council fourth non-small cell lung cancer radiotherapy study: clinical trial of radiotherapy for good-performance-status patients with inoperable non-small cell lung cancer too large in volume for radical radiotherapy
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
Condition
Lung (non-small cell) cancer
Intervention
1. Radiotherapy Regimen A: A total dose of 17 Gy given as two fractions of 8.5 Gy with an interval of one week between the fractions.
2. Radiotherapy Regimen B: A total dose of 39 Gy given as thirteen fractions of 3 Gy during three weeks in daily fractions five days per week.
Radiotherapy should start within two weeks of randomisation. If the patient has superior vena cava obstruction, a course of steroids may be given during the period of radiotherapy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/01/2002
Overall trial end date
31/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primarily untreated, microscopically confirmed non-small cell lung cancer
2. Performance status World Health Organisation (WHO) grade zero to two
3. Disease too advanced for radical radiotherapy
4. Either sex, any age
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
1. Previous surgery, radiotherapy or chemotherapy for non-small cell lung cancer
2. Other previous concomitant malignant disease. Except previous basal cell carcinoma or in situ carcinoma of the cervix
3. Evidence of distant metastases outside of the locoregional volume
Recruitment start date
01/01/2002
Recruitment end date
31/12/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
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
Basic results (scientific)
Publication list