Non-small Cell Lung Cancer
Conditions
Keywords
Bronchial stents, Airway obstruction, Non-small cell lung cancer
Brief summary
To investigate whether the use of airways stents (metal tubes to open and keep open narrowed airways) together with the standard treatment increases the proportion of patients who can complete a 6min walking distance (6MWD) test at 2 weeks +/- 2days in patients with breathlessness due to lung cancer, when compared to standard treatment alone.
Interventions
OTHERArterial puncture
Patients will undergo arterial blood gas sampling from the radial artery. This will be done by experienced doctors who are highly skilled in this procedure.
OTHERVenepuncture
Blood samples for baseline biochemistry, full blood count, and clotting screen will be taken. In patients additionally providing optional consent blood will be taken for laboratory based basic science research into lung cancer carcinogenesis and pharmacogenetics. Blood will be taken by qualified and experienced nurses, doctors and phlebotomists.
PROCEDUREGeneral anaesthetic
Patients randomised into the stenting arm will undergo rigid bronchoscopy under general anaesthetic.
PROCEDUREInpatient stays
Patients randomised into the stenting arm will be admitted overnight for the procedure
OTHERWalking test
All patients will be asked to complete a 6 minute walking test at baseline and on day 15. Patients randomised into the stent arm (Arm A) will complete a further 6 minute walking test at 24 hours post-stent
OTHERSpirometry & flow volume loop assessment
All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.
OTHERBiopsy material
For patients randomised to stenting and giving additional voluntary consent, 2 pairs of biopsies of tumour tissue, and 1 pair of biopsies of normal airways tissue will be taken for basic scientific research into lung cancer carcinogenesis, and pharmacogenetics.
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to give informed written consent in the English language * Able and willing to attend St Georges Hospital / Royal Marsden Hospital for stent insertion (if allocated) and documentation of 6 minute walking distance. * Willing to re-attend for follow-up and 6 minute walking distance at St Georges Hospital / Royal Marsden Hospital 2 weeks later (all patients) * Diagnosis of non-small cell lung cancer with centrally placed tumour with some degree of airway obstruction from information from bronchoscopy or CT scan. * ECOG Performance status: 0-3
Exclusion criteria
* Relative contraindications to stenting, e.g. bleeding abnormality or anticoagulation problems. * Pregnancy * Radically treatable disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the proportion of patients achieving a 50% improvement in the distance walked after 2 weeks +/- 2 days of treatment as compared to their pre-treatment assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare lung function tests from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group. | — |
| To compare other symptoms such as anxiety and breathlessness, as measured by standard scales (e.g. VAS, Borg scales) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group | — |
| To measure quality of life with standard questionnaires | — |
| To compare arterial blood gases (oxygenation of blood) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group. | — |
| To document any subsequent treatments given to patients in each group | — |
| To establish the feasibility of collecting fresh and formalin fixed, paraffin embedded tumour and normal bronchial tissue, and germ-line DNA for future research into NSCLC carcinogenesis and corollary translational work | — |
| Formal objective response assessment is not required at 3 months, but where this is possible, this will be described | — |
| To compare survival rates at 6 months and 1 year between the stented group and standard treatment group | — |
Countries
United Kingdom
Contacts
Primary ContactDr Mary O'Brien
Outcome results
None listed