Post-Operative Radiotherapy for Non-Small Cell Lung Cancer

ISRCTN	ISRCTN46536242
DOI	https://doi.org/10.1186/ISRCTN46536242
Secondary identifying numbers	LU11

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 15/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Post-Operative Radiotherapy for Non-Small Cell 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	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
Completion date	31/12/2002

Eligibility

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
Key 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
Key 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
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/1996	15/11/2019	Yes	No

Editorial Notes

15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
19/01/2016: No publications found on PubMed.