NCT05065086

Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Timeline

• Start date: 2021-09-02
• Primary completion: 2022-07-30
• Completion: 2022-07-30
• First posted: 2021-10-01
• Last updated: 2021-10-08

Locations

1 site across 1 country: United Kingdom