Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/04/2015
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

- - -

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

ILT-2

Study information

Scientific title

A Randomised Trial Comparing External Beam Radiotherapy Alone With External Beam Radiotherapy Plus Intraluminal Irradiation for Palliation in 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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lung (non-small cell) cancer

Intervention

1. Schedule A: External beam radiotherapy, a maximum subcutaneous dose of 3250 cGy given in eight fractions over 10 days with a margin of 2 cm around the tumour.

2. Schedule B: External beam radiotherapy, a maximum subcutaneous dose of 3250 cGy given in eight fractions over 10 days with a margin of 2 cm around the tumour. Followed by intraluminal radiotherapy, a single dose of 1500 cGy to be given on the last day of external beam 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

01/01/2000

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Biopsy proven non-small cell lung cancer
2. Fit to receive bronchoscopy
3. Fit to receive external beam radiotherapy
4. Any age
5. Shortness of breath, cough, haemoptysis, dysphagia or chest pain resulting from a primary bronchial tumour
6. No previous or concomitant malignancy, except basal cell carcinomas
7. No symptomatic metastases requiring external beam radiotherapy
8. No previous chest irradiation for lung cancer
9. No bilateral lung tumours or tracheal tumours

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

UK Co-ordinating Committee for Cancer Research (UKCCCR)

Sponsor details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Cancer organisations (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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