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

• Conditions: Head and Neck Squamous Cell Carcinoma

• Registration Number: NCT05065086
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2021-09-02
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-30
• Status Verified: 2021-10
• Study First Posted: 2021-10-01
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-08
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 18 years and older.
• Primary OPSCC.
• Index cancer treated with TORS without adjuvant therapy.
• Any post-operative TNM classification.
• TORS performed on or before 31st July 2019.

Exclusion Criteria

• TORS preformed for diagnostic or palliative intentions.
• Known distant metastasis at time of TORS.
• Nasopharyngeal and thyroid cancers.
• Patients undergoing neoadjuvant or adjuvant chemotherapy, biotherapy, immunotherapy or radiotherapy to either the neck or primary site.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local recurrence-free survival time	At 2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival time	At 2 and 5 years
Post-operative haemorrhage time	Within 30 days
Disease-free survival time	At 2 and 5 years
Disease-specific survival time	At 2 and 5 years

Trial Locations

Locations (1)

The Royal Marsden Hospital; 🇬🇧 London, United Kingdom