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

ISRCTN ISRCTN83218866
DOI https://doi.org/10.1186/ISRCTN83218866
Secondary identifying numbers ILT-2
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
08/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

- - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA Randomised Trial Comparing External Beam Radiotherapy Alone With External Beam Radiotherapy Plus Intraluminal Irradiation for Palliation in Lung Cancer
Study hypothesisNot provided at time of registration
Ethics approval(s)Not provided at time of registration
ConditionLung (non-small cell) cancer
Intervention1. 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Overall study end date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Participant inclusion criteria1. 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 exclusion criteriaNot provided at time of registration
Recruitment start date01/01/2000
Recruitment end date31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

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

ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Research organisation

Cancer organisations (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan