Phase
Condition
Oral Cancer
Head And Neck Cancer
Treatment
Voice recording, ENT (Ear, Nose and Throat) examination including transnasal fiberendoscopy, and VHI-30-questionnaire
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histopathologically proven carcinoma in-situ or invasive LSCC or HPSCC (innon-surgically treated carcinoma: clinical/radiologic stage I-IV (excluding M1)according to the Union for International Cancer Control (UICC) / Tumor (T), Nodes (N), and Metastases (M) (TNM) 8th ed.; in surgically treated carcinoma: pathologicalstage I-IV (excluding M1) according to the UICC / TNM 8th ed.).
≥ 18 years of age.
Treatment with curative intent, regardless of treatment modality (mono- ormultimodal). Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignantnon-metastatic tumors, with clinically confirmed complete remission 6 months aftertreatment and life expectancy of at least 6 months are eligible. Patients withsurgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinomaof the skin and/or other surgically treated non-head and neck Tis are eligible,although the treatment was within the 6 months before enrolment.
Clinical confirmation of complete remission of LSCC or HPSCC through Ear, Nose andThroat (ENT) examination, including fiberendoscopy of the pharynx and larynx, at thetime of enrolment, during the period of eligibility (6 to 30 months aftertreatment). Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignantnon-metastatic tumors, with clinically confirmed complete remission 6 months aftertreatment and life expectancy of at least 6 months are eligible. Patients withsurgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinomaof the skin and/or other surgically treated non-head and neck Tis are eligible,although the treatment was within the 6 months before enrolment.
Informed consent as documented by signature.
Exclusion
Exclusion Criteria:
Total laryngectomy as primary therapy.
Any local, regional, and systemic laryngeal or hypopharyngeal cancerpersistence/progression, or recurrence before enrolment. Excepted: Patients with synchronous laryngeal/hypopharyngeal malignantnon-metastatic tumors, with clinically confirmed complete remission 6 months aftertreatment and life expectancy of at least 6 months are eligible.
Any local, regional, and systemic tumor persistence/progression, or recurrence ofsynchronous (larynx and hypopharynx included) or metachronous (before/after thediagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant tumors within 6months before enrolment. Excepted: Patients with surgically treated progredient or recurrent locally definedTis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/ornon-head and neck progredient or recurrent Tis.
Any previously treated LSCC/HPSCC or treated second primary malignancies of thelarynx or hypopharynx before the diagnosis and treatment of the investigatedLSCC/HPSCC (= index tumor).
Presence of any medical, psychological, familial, sociological, or geographicalconditions expected to potentially hamper the compliance with the study protocol.
Inability to follow procedures (e.g., inability to read) or insufficient knowledgeof any project language (German and French).
Study Design
Connect with a study center
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital
Bern, 3010
SwitzerlandActive - Recruiting
Department of Oto-Rhino-Larnygology, Head and Neck Surgery, University Hospital Zurich
Zurich, 8091
SwitzerlandActive - Recruiting

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