Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer

Phase 3

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: Arterial puncture; Other: Venepuncture; Procedure: General anaesthetic; Procedure: Inpatient stays; Other: Walking test; Other: Spirometry & flow volume loop assessment; Other: Biopsy material

• Registration Number: NCT01003522
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Last Update Submitted: 2009-10-27
• Study First Posted: 2009-10-28
• Last Update Posted: 2009-10-28
• Primary Completion: 2010-03
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm A	Inpatient stays	Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Treatment Arm A	Arterial puncture	Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Treatment Arm A	Venepuncture	Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Treatment Arm A	General anaesthetic	Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Treatment Arm A	Walking test	Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Treatment Arm A	Spirometry & flow volume loop assessment	Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Treatment Arm A	Biopsy material	Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
Treatment Arm B	Arterial puncture	Standard palliative treatment and standard dyspnoea symptom control.
Treatment Arm B	Venepuncture	Standard palliative treatment and standard dyspnoea symptom control.
Treatment Arm B	Walking test	Standard palliative treatment and standard dyspnoea symptom control.
Treatment Arm B	Spirometry & flow volume loop assessment	Standard palliative treatment and standard dyspnoea symptom control.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 survival rates at 6 months and 1 year between the stented group and 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

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom