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

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05065086
Collaborator
Institute of Cancer Research, United Kingdom (Other)
500
Enrollment
1
Location
10.9
Anticipated Duration (Months)
46
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
    Actual Study Start Date :
    Sep 2, 2021
    Anticipated Primary Completion Date :
    Jul 30, 2022
    Anticipated Study Completion Date :
    Jul 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Local recurrence-free survival time [At 2 years]

    Secondary Outcome Measures

    1. Overall survival time [At 2 and 5 years]

    2. Disease-specific survival time [At 2 and 5 years]

    3. Disease-free survival time [At 2 and 5 years]

    4. Post-operative haemorrhage time [Within 30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Royal Marsden Hospital London United Kingdom SW3 6JJ

    Sponsors and Collaborators

    • Royal Marsden NHS Foundation Trust
    • Institute of Cancer Research, United Kingdom

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royal Marsden NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05065086
    Other Study ID Numbers:
    • CCR5370
    First Posted:
    Oct 1, 2021
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Royal Marsden NHS Foundation Trust
    Primary OPSCC
    Additional relevant MeSH terms:
    Squamous Cell Carcinoma of Head and Neck
    Oropharyngeal Neoplasms
    Recurrence

    Study Results

    No Results Posted as of Oct 8, 2021