Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

March 29, 2023 updated by: Susanne Scott, Rigshospitalet, Denmark

Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma

To investigate the treatment related effects of transoral robotic surgery (TORS) or oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.

Study Overview

Detailed Description

Patients are enrolled prospectively at the department of Otorhinolaryngology, Head and Neck Surgery & Audiology at Copenhagen University Hospital, Rigshospitalet.

All eligible patients with histologically verified squamous cell carcinoma of the oropharynx regardless of treatment option (as long as the intent is curative) can be included.

Outcome measures are assessed at baseline and repeated 3 and 12 months after treatment.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible patients with histologically verified oropharyngeal squamous cell carcinoma treated either with TORS or primary radiotherapy (with or without chemotherapy) with curative intent.

Description

Inclusion Criteria:

TORS group:

  1. WHO performance status 0-2
  2. Squamous cell carcinoma of the oropharynx
  3. TNM: T1-2, N0-1 (without of evidence of extra capsular extent), M0.
  4. No previous head and neck cancer
  5. Absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
  6. Signed written consent.
  7. Cancer eligible for surgery in the absence of significant trismus.

Oncological group:

  1. WHO performance status 0-2
  2. Squamous cell carcinoma of the oropharynx
  3. Qualified for curative intended oncological treatment
  4. Signed written consent

Exclusion Criteria:

TORS group:

  1. Serious co-morbidity
  2. Distant metastasis
  3. Previous radiotherapy to the head and neck region.
  4. Concurrent treatment eller investigations for another cancer, except carcinoma in situ.

Oncological group:

  1. Previous radiotherapy to the head and neck region.
  2. Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
  3. Presence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
  4. Presence of facors that inhibit the patient from completing the treatment.
  5. Previous head and neck cancer
  6. Distant metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oropharyngeal carcinoma (excluding M+ stage)

Eligible patients with histologically verified early stage squamous cell carcinoma of the oropharynx.

Patients will be treated in accordance with current hospital protocols with transoral robotic surgery (T1-2, N1, M0) or radio(chemo)therapy (any T-stage, any N-stage, M0).

In the absence of severe mobidity patients with early stage disease (T1-2, N1, M0) were offered TORS, as an alternative to the standard of care (radiotherapy).
As the standard of care radiotherapy was offered to all of the patients. Patients that qualified for both TORS and radiotherapy were free to choose between the two.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Altered salivatory function
Time Frame: 3 and 12 months follow up
Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment.
3 and 12 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in swallowing function (MBSS)
Time Frame: 3 and 12 months as well as 3 years after treatment
Assessed using modified barium swallowing studies (MBSS). Evaluated as change from baseline.
3 and 12 months as well as 3 years after treatment
Changes in swallowing function (FEES)
Time Frame: 3 and 12 months as well as 3 years after treatment
Assessed using fiber endoscopic evaluation of swallowing function (FEES). Evaluated as change from baseline.
3 and 12 months as well as 3 years after treatment
Change to quality of life scores (MDADI)
Time Frame: 3 and 12 months as well as 3 years after treatment
Assessed using the MD Anderson Dysphagia Inventory (MDADI) questionnaire. Evaluated as change from baseline.
3 and 12 months as well as 3 years after treatment
Change to quality of life scores (EORTC QLQ-C30)
Time Frame: 3 and 12 months as well as 3 years after treatment
Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Evaluated as change from baseline.
3 and 12 months as well as 3 years after treatment
Change to quality of life scores (EORTC QLQ-H&N35)
Time Frame: 3 and 12 months as well as 3 years after treatment
Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H&N35 questionnaire. Evaluated as change from baseline.
3 and 12 months as well as 3 years after treatment
Treatment related pain
Time Frame: For as long as the patient needs analgesics or up to three months
Assessed using a pain diary based on a 10 point visual analog scale (VAS). 0 being no pain and 10 the most severe pain. Registrered in increments of 1 (i.e. 3,5 is not an accepted score whereas 3 or 4 are).
For as long as the patient needs analgesics or up to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Christian von Buchwald, MD, dr. med., Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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