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Clinical Trial Summary

Retrospective observational cohort study investigating Single modality Trans Oral Robotic surgery for primary oropharyngeal cancer: exploring the impact of surgical Margins on local disease recurrence.


Clinical Trial Description

The STORM study will examine transoral surgery performed before 31st July 2019. STORM is a retrospective observational cohort study, involving international centres performing TORS for primary OPSCC. The main aim of this study is to explore the impact of surgical margins on local disease recurrence in primary oropharyngeal squamous cell carci-noma treated with transoral robotic surgery (TORS) without adjuvant therapy. The primary objective is to report local recurrence-free survival. The primary endpoint will be Local recurrence-free survival time. The secondary objectives are to report overall survival, disease-specific survival and disease-free survival, and to report post-operative haemor-rhage rates. The secondary endpoints include Overall survival time, Dis-ease-specific survival time, Disease-free survival time, Post-operative haemorrhage time. Exploratory objective to identify a clinically relevant cut-off for surgical margins as a predictor of local disease recurrence. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05065086
Study type Observational
Source Royal Marsden NHS Foundation Trust
Contact John Hardman, MBChB
Phone 442073528171
Email [email protected]
Status Recruiting
Phase
Start date September 2, 2021
Completion date July 30, 2022

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