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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03418909
Other study ID # H-1-2014-033
Secondary ID H-17015164
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date June 30, 2024

Study information

Verified date March 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date June 30, 2024
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Altered salivatory function Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment. 3 and 12 months follow up
Secondary Changes in swallowing function (MBSS) Assessed using modified barium swallowing studies (MBSS). Evaluated as change from baseline. 3 and 12 months as well as 3 years after treatment
Secondary Changes in swallowing function (FEES) 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
Secondary Change to quality of life scores (MDADI) 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
Secondary 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. 3 and 12 months as well as 3 years after treatment
Secondary 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. 3 and 12 months as well as 3 years after treatment
Secondary 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). For as long as the patient needs analgesics or up to three months
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