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

Royal Marsden NHS Foundation Trust

Status and phase: Unknown; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Procedure: General anaesthetic; Other: Spirometry & flow volume loop assessment; Other: Walking test; Other: Venepuncture; Other: Biopsy material; Other: Arterial puncture; Procedure: Inpatient stays

Study type: Interventional

Funder types: Other

Identifiers

NCT01003522

CCR2987

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Treatment Arm A

Other group

Description:

Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control

Treatment:

Other: Biopsy material

Other: Arterial puncture

Procedure: Inpatient stays

Other: Walking test

Procedure: General anaesthetic

Other: Spirometry & flow volume loop assessment

Other: Venepuncture

Treatment Arm B

Other group

Description:

Standard palliative treatment and standard dyspnoea symptom control.

Treatment:

Other: Arterial puncture

Other: Walking test

Other: Spirometry & flow volume loop assessment

Other: Venepuncture