Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes