Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma
NCT ID: NCT03418909
Last Updated: 2023-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
44 participants
OBSERVATIONAL
2017-04-01
2024-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
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).
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Susanne Scott
MD, PhD student
Principal Investigators
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Christian von Buchwald, MD, dr. med.
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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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.
Other Identifiers
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H-17015164
Identifier Type: OTHER
Identifier Source: secondary_id
H-1-2014-033
Identifier Type: -
Identifier Source: org_study_id
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