Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LU11
Study information
Scientific title
Post-Operative Radiotherapy for Non-Small Cell Lung Cancer
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Lung (non-small cell) cancer
Intervention
Patients are randomised two to four weeks postoperatively to either:
1. Schedule R: Radiotherapy 40 Gy given in daily fractions five days a week over three weeks to mediastinum starting four to six weeks post-operatively.
2. Schedule NoR: No further specific treatment including post-operative radiotherapy unless or until the disease recurrence.
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. Either sex, aged 75 years or less
2. World Health Organisation (WHO) performance status zero to two
3. Lung and cardiac function adequate for proposed resection
4. pT1 pN1 M0, pT2 pN1 M0, pT1 pN2 M0 or pT2 pN2 M0 non-small cell lung cancer
5. Complete resection of non-small cell lung cancer
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration.
Total final enrolment
308
Participant exclusion criteria
1. Previous specific anti-cancer treatment for current disease
2. Presence of other malignant disease, except basal cell carcinoma or in situ carcinoma of the cervix
3. Presence of other serious condition contraindicating surgery or radiotherapy
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
1996 results in: https://www.ncbi.nlm.nih.gov/pubmed/8761382 (added 15/11/2019)