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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05065086

Acronym

STORM

Enrollment

500

Registered

2021-10-01

Start date

2021-09-02

Completion date

2022-07-30

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Primary OPSCC

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Local recurrence-free survival time	At 2 years

Secondary

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

Countries

United Kingdom

Contacts

Primary ContactJohn Hardman, MBChB

johncharles.hardman@nhs.net442073528171

Backup ContactAmy O'Reilly

amy.o'reilly@rmh.nhs.uk020 8661 3567

Outcome results