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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN66281665
• Date of registration: 19/08/2002
• Primary sponsor: Northern and Yorkshire Clinical Trials and Research Unit (UK)
• Public 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 N/A
• Date of first enrolment: Jan 1 1997
• Target sample size: Not provided at time of registration
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN66281665
• Study type: Interventional
• Study design: Randomised controlled trial

Countries of recruitment

United Kingdom

Contacts

• Name: - -

Key inclusion & exclusion criteria

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
Exclusion criteria: Does not match inclusion criteria

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Lung (non-small cell) cancer

Intervention(s)

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).

Primary Outcome(s)

Not provided at time of registration

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

LUN/INT

Source(s) of Monetary Support

Northern & Yorkshire Clinical Trials and Research Unit (UK)

Secondary Sponsor(s)

N/A