Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
NCT ID: NCT05065086
Last Updated: 2021-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2021-09-02
2022-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Locations
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The Royal Marsden Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CCR5370
Identifier Type: -
Identifier Source: org_study_id
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