Oropharynx CancerNCT03418909
Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma
An observational study of Oropharynx Cancer and Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer, Pain, Swallowing Disorder
- What is being tested?
- Primary Trans Oral Robotic Surgery (TORS) and Radio(chemo)therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2017to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- TORS group:
- WHO performance status 0-2
- Squamous cell carcinoma of the oropharynx
- TNM: T1-2, N0-1 (without of evidence of extra capsular extent), M0.
- No previous head and neck cancer
- Absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
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- Signed written consent.
- Cancer eligible for surgery in the absence of significant trismus.
- Oncological group:
- WHO performance status 0-2
- Squamous cell carcinoma of the oropharynx
- Qualified for curative intended oncological treatment
- Signed written consent
Who cannot join
- TORS group:
- Serious co-morbidity
- Distant metastasis
- Previous radiotherapy to the head and neck region.
- Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
- Oncological group:
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- Previous radiotherapy to the head and neck region.
- Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
- Presence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
- Presence of facors that inhibit the patient from completing the treatment.
- Previous head and neck cancer
- Distant metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Oropharynx Cancer, Pain, Swallowing Disorder, Quality of Life, Saliva Altered, Human Papilloma Virus
- Being tested
- Primary Trans Oral Robotic Surgery (TORS), Radio(chemo)therapy
- Medical subject headings
- Oropharyngeal Neoplasms, Pain, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Trans Oral Robotic Surgery (TORS)Procedure or surgery
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).
Radio(chemo)therapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Primary Trans Oral Robotic Surgery (TORS); Radiation: Radio(chemo)therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered salivatory function
Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment.
Measured: 3 and 12 months follow up
Secondary outcomes (6)
Changes in swallowing function (MBSS)
Assessed using modified barium swallowing studies (MBSS). Evaluated as change from baseline.
Measured: 3 and 12 months as well as 3 years after treatment
Changes in swallowing function (FEES)
Assessed using fiber endoscopic evaluation of swallowing function (FEES). Evaluated as change from baseline.
Measured: 3 and 12 months as well as 3 years after treatment
Change to quality of life scores (MDADI)
Assessed using the MD Anderson Dysphagia Inventory (MDADI) questionnaire. Evaluated as change from baseline.
Measured: 3 and 12 months as well as 3 years after treatment
Change to quality of life scores (EORTC QLQ-C30)
Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Evaluated as change from baseline.
Measured: 3 and 12 months as well as 3 years after treatment
Change to quality of life scores (EORTC QLQ-H&N35)
Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H\&N35 questionnaire. Evaluated as change from baseline.
Measured: 3 and 12 months as well as 3 years after treatment
Treatment related pain
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).
Measured: For as long as the patient needs analgesics or up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Apr 2017
- Primary completion31 Dec 2021
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Scott, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian von Buchwald, MD, dr. med., Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418909
- Sponsor's protocol ID
- H-1-2014-033
- Other IDs
- H-17015164
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2018
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scott SI, Madsen AKO, Rubek N, Charabi BW, Wessel I, Jensen CV, Friborg J, von Buchwald C. Dysphagia and QoL 3 Years After Treatment of Oropharyngeal Cancer With TORS or Radiotherapy. Laryngoscope. 2023 Aug;133(8):1893-1898. doi: 10.1002/lary.30410. Epub 2022 Oct 14.
PubMed 36239625
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03418909
- Acronym / sponsor ID
- H-1-2014-033
- Conditions
- Oropharynx Cancer, Pain, Swallowing Disorder, Quality of Life, Saliva Altered, Human Papilloma Virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal carcinoma (excluding M+ stage) | – | Procedure: Primary Trans Oral Robotic Surgery (TORS), Radiation: Radio(chemo)therapyEligible 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- WHO performance status 0-2
- Squamous cell carcinoma of the oropharynx
- TNM: T1-2, N0-1 (without of evidence of extra capsular extent), M0.
- No previous head and neck cancer
- Absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
Key exclusion criteria (12 listed)
- Serious co-morbidity
- Distant metastasis
- Previous radiotherapy to the head and neck region.
- Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
- Previous radiotherapy to the head and neck region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Oropharyngeal carcinoma (excluding M+ stage) |
| Radio(chemo)therapyAs 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. | Radiation | Oropharyngeal carcinoma (excluding M+ stage) |
Primary outcome
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.
6 secondary outcomes
Changes in swallowing function (MBSS)
Time frame: 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
Change to quality of life scores (MDADI)
Time frame: 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
Change to quality of life scores (EORTC QLQ-H&N35)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 36239625Scott SI, Madsen AKO, Rubek N, Charabi BW, Wessel I, Jensen CV, Friborg J, von Buchwald C. Dysphagia and QoL 3 Years After Treatment of Oropharyngeal Cancer With TORS or Radiotherapy. Laryngoscope. 2023 Aug;133(8):1893-1898. doi: 10.1002/lary.30410. Epub 2022 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian von Buchwald, MD, dr. med. study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharynx Cancer and Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Altered salivatory function (time frame: 3 and 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.