Clinical trial NCT03418909: Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma
Official title: Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oropharynx Cancer
Pain
Swallowing Disorder
Quality of Life
Saliva Altered
Human Papilloma Virus
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Altered salivatory function
timeFrame: 3 and 12 months follow up
Secondary outcomes:
measure: Changes in swallowing function (MBSS)
timeFrame: 3 and 12 months as well as 3 years after treatment
measure: Changes in swallowing function (FEES)
timeFrame: 3 and 12 months as well as 3 years after treatment
measure: Change to quality of life scores (MDADI)
timeFrame: 3 and 12 months as well as 3 years after treatment
measure: Change to quality of life scores (EORTC QLQ-C30)
timeFrame: 3 and 12 months as well as 3 years after treatment
measure: Change to quality of life scores (EORTC QLQ-H&N35)
timeFrame: 3 and 12 months as well as 3 years after treatment
measure: Treatment related pain
timeFrame: For as long as the patient needs analgesics or up to three months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Christian von Buchwald, MD, dr. med.
role: STUDY_DIRECTOR
References: