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

LUN/INT

Study information

Scientific title

A phase II randomised trial to assess external beam radiotherapy and intraluminal bronchial brachytherapy as re-treatment in patients with lung cancer who have received primary palliative external beam therapy

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Lung (non-small cell) cancer

Intervention

Patients with respiratory symptoms requiring re-treatment after palliative external beam radiotherapy are randomised to one of two regimens:

1. External Beam Radiotherapy:
Patients will be treated by the radiotherapist using whatever schedule is thought appropriate. There will be no standardisation of treatment although 20 Gy in five fractions over five to seven days, with appropriate attention to shielding of the spinal cord, where indicated, is recommended.

2. Intraluminal Bronchial Brachytherapy:
Intraluminal Bronchial Brachytherapy 10 Gy at 1 cm. To be carried out as a day case procedure at Cookbridge Hospital, Leeds using fibre-optic bronchoscopy and standard published protocol (Goldman et al, 1993).

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1997

Overall trial end date

07/05/1997

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed non-small cell cancer
2. Respiratory symptoms due to lung cancer
3. Previous palliative external beam radiotherapy
4. Expected survival at least two months
5. When patient requires retreatment, radiotherapist considers suitability for further course of external beam radiotherapy or intraluminal bronchial brachytherapy
6. Well enough to tolerate fibre optic bronchoscopy: at bronchoscopy patient has endobronchial disease and it is still considered that the patient could be treated with intraluminal bronchial brachytherapy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/1997

Recruitment end date

07/05/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Northern and Yorkshire Clinical Trials and Research Unit (UK)

Sponsor details

17 Springfield Mount
Leeds
LS2 9NG
United Kingdom

Sponsor type

Research organisation

Website

http://www.leeds.ac.uk/medicine/nyctru/nyctru_page1.htm

Funders

Funder type

Research organisation

Funder name

Northern & Yorkshire Clinical Trials and Research Unit (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

30/11/2015: No publications found in PubMed.