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

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Denmark
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Procedure: Primary Trans Oral Robotic Surgery (TORS)
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).
Radiation: Radio(chemo)therapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-1-2014-033
  • H-17015164 (Other Identifier: Regional ethical committee)

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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