Comprehensive endoscopic lung cancer staging to optimize radiation planning in patients with locally advanced non-small cell lung cancer

Not Applicable

Recruiting

• Conditions: lung cancer; stage III NSCLC; Cancer - Lung - Non small cell; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12617000333314
• Lead Sponsor: Daniel Steinfort

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-03
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Patients with known/suspected non-small cell lung cancer (NSCLC) and suspected/known mediastinal metastases. (stage III A-B based on mediastinal nodal involvement)

Exclusion Criteria

i. medical co-morbidities preclude bronchoscopy
ii. medical co-morbidities or known pathologic extent of disease precludes consideration of radiotherapy
iii. age <18 or >80 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of patients with Stage III NSCLC in whom systematic endoscopic mediastinal staging detects PET-occult lymph node NSCLC metastases[Endoscopic staging procedure]

Secondary Outcome Measures

Name	Time	Method
Impact of T-stage on likelihood of discrepant staging findings[Endoscopic staging procedure ];Procedure duration (measured in minutes, recorded by investigators with stopwatch[at time of endoscopic staging procedure];Procedural complications (pneumothorax, infection, bleeding). All such complications will be determined through post-procedure clinical observation prior to discharge from hospital[at time of endoscopic staging procedure];Proportion of patients with endoscopy-demonstrated benign lymph nodes at sites of FDG-avidity on PET/CT<br>[Endoscopic staging procedure];Dosimetry impact of endoscopic staging (in patients where PET and Endoscopy demonstrate discordant staging outcomes). Dosimetry will be based on Radiation treatment plans established for PET versus Endoscopy-based Stage (only one plan will be delivered to patients)[Following endoscopic staging procedure]