NCT05065086

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

11 months

First QC Date

September 6, 2021

Last Update Submit

October 1, 2021

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Primary OPSCC

Outcome Measures

Primary Outcomes (1)

  • Local recurrence-free survival time

    At 2 years

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of Primary OPSCC with Index cancer treated with TORS, without adjuvant therapy, on or before 31st July 2019.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Central Study Contacts

John Hardman, MBChB

CONTACT

442073528171johncharles.hardman@nhs.net

Amy O'Reilly

CONTACT

020 8661 3567amy.o'reilly@rmh.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2021

First Posted

October 1, 2021

Study Start

September 2, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)