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NCT05065086 Clinical Trial

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

Head and Neck Squamous Cell Carcinoma Clinical Trial

— STORM  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05065086
Other study ID # CCR5370
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2, 2021
Est. completion date July 30, 2022

Study information
Verified date October 2021
Source Royal Marsden NHS Foundation Trust
Contact John Hardman, MBChB
Phone 442073528171
Email johncharles.hardman@nhs.net
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date July 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom The Royal Marsden Hospital London

Sponsors (2)
Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local recurrence-free survival time At 2 years
Secondary Overall survival time At 2 and 5 years
Secondary Disease-specific survival time At 2 and 5 years
Secondary Disease-free survival time At 2 and 5 years
Secondary Post-operative haemorrhage time Within 30 days
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