- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03418909
Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma
Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
- 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
Exclusion Criteria:
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:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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
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Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment.
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3 and 12 months follow up
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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
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Assessed using modified barium swallowing studies (MBSS).
Evaluated as change from baseline.
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3 and 12 months as well as 3 years after treatment
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Changes in swallowing function (FEES)
Time Frame: 3 and 12 months as well as 3 years after treatment
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Assessed using fiber endoscopic evaluation of swallowing function (FEES).
Evaluated as change from baseline.
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3 and 12 months as well as 3 years after treatment
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Change to quality of life scores (MDADI)
Time Frame: 3 and 12 months as well as 3 years after treatment
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Assessed using the MD Anderson Dysphagia Inventory (MDADI) questionnaire.
Evaluated as change from baseline.
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3 and 12 months as well as 3 years after treatment
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Change to quality of life scores (EORTC QLQ-C30)
Time Frame: 3 and 12 months as well as 3 years after treatment
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Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
Evaluated as change from baseline.
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3 and 12 months as well as 3 years after treatment
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Change to quality of life scores (EORTC QLQ-H&N35)
Time Frame: 3 and 12 months as well as 3 years after treatment
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Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H&N35 questionnaire.
Evaluated as change from baseline.
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3 and 12 months as well as 3 years after treatment
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Treatment related pain
Time Frame: For as long as the patient needs analgesics or up to three months
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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).
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For as long as the patient needs analgesics or up to three months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Christian von Buchwald, MD, dr. med., Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Deglutition Disorders
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Oropharyngeal Neoplasms
- Papilloma
Other Study ID 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
Studies a U.S. FDA-regulated device product
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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