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

ISRCTN	ISRCTN53968814
DOI	https://doi.org/10.1186/ISRCTN53968814
Secondary identifying numbers	LU13

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
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	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
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

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Not provided at time of registration.
Key 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
Key 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
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2002

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

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

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

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/1994	15/11/2019	Yes	No

15/11/2019: Publication reference added.