Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall study start date
01/01/2002
Overall study 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(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study 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)
UK Medical Research Council, 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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/1996 | 15/11/2019 | Yes | No |