Clinical trial · Observational
Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma
Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma
NCT03418909CI-TRIAL-00065173unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus | — | UNRESOLVED | — |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Saliva Altered | — | UNRESOLVED | — |
| Swallowing Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary Trans Oral Robotic Surgery (TORS) | Procedure | — | UNRESOLVED |
| Radio(chemo)therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Oropharyngeal carcinoma (excluding M+ stage)
- description
- 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).
- interventionNames
- Procedure: Primary Trans Oral Robotic Surgery (TORS)
- Radiation: Radio(chemo)therapy
Primary outcomes (1)
- measure
- Altered salivatory function
- timeFrame
- 3 and 12 months follow up
- description
- Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment.
Secondary outcomes (6)
- measure
- Changes in swallowing function (MBSS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDScott 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. PMID 36239625