Superficial Head and Neck Cancer
Conditions
Interventions
Transoral surgery for superficial head and neck cancer
Sponsors
Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A histologically confirmed diagnosis of squamous cell carcinoma (not including severe dysplasia) 2) A clinically confirmed diagnosis that the depth of invasion by the primary tumor does not reach the mascularis propria 3) Lesions primarily located in the oropharynx, hypopharynx or supraglottis (not including lesions that invade the cervical esophagus even if the lesion is primarily located in the hypopharynx) 4) A clinical diagnosis that the primary lesion is 4 cm or less in diameter 5) No evidence of lymph node metastasis or distant metastasis on computed tomography of the neck, chest or abdomen (cN0M0) (Regions including the cranial base should be scanned, with a slice thickness of 10 mm or less.) 6) If multiple lesions are detected at the time of registration, up to 2 accessory lesions (a total of 3 lesions including the primary lesion). The size of the accessory lesions is not specified. 7) An age of 20 years to 75 years or younger at the time of registration 8) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 9) All of the following conditions are satisfied (The most recent test data obtained within 28 days before registration are used for all examination variables. Tests performed on the same day of the week 4 weeks before the day of registration are acceptable.) a. Leukocyte count >= 3000/uL b. Hemoglobin level >= 10 g/dL c. Platelet count >=100 x 103/uL d. Aspartate aminotransferase and alanine transaminase levels 3 times or less the institutional upper limit of normal e. Total bilirubin levels 1.5 times or less the institutional upper limit of normal f. No electrocardiographic abnormalities requiring treatment on 12-lead electrocardiograms obtained at rest 10) Written informed consent for participation in the study is obtained.
Exclusion criteria
Exclusion criteria: 1) Allergy to iodine 2) Temporary discontinuation of anticoagulant drugs or antiplatelet agents to allow transoral surgery is not possible. 3) Incurable double cancers 4) At the time of registration the patient is scheduled to undergo radiotherapy for multiple or double cancers of the head and neck. 5) At the time of registration the patient is scheduled to receive chemotherapy (including endocrine therapy, molecular targeted therapy, and immune checkpoint inhibitors) for multiple or double cancers. 6) Residual lesions after radiotherapy and chemoradiotherapy 7) Women who might be pregnant 8) Participation in the study is precluded by the presence of psychosis or psychiatric symptoms. 9) Active infection (a fever of >=38 degrees and bacterial infection confirmed on imaging studies or bacteriologic examinations)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II study The incidences of adverse events associated with transoral surgery for superficial head and neck cancer Phase III study Primary endpoint: the overall survival at 3 years in patients who undergo transoral surgery for superficial head and neck cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase III study Secondary endpoints: the 3-year and 5-year distant recurrence-free survival, relapse-free survival, cause-specific survival, larynx-preservation survival, in patients who undergo transoral surgery for superficial head and neck cancer; the 5-year overall survival in patients who undergo transoral surgery for superficial head and neck cancer; the rate of local recurrence, the rate of metastatic recurrence, the incidence of multiple cancers, the incidence of double cancers, the incidences of adverse events associated with transoral surgery, the rate of larynx function preservation; examinations of voice, swallowing function, and pain; and comparison with data from the National Registration Survey of Superficial Head and Neck Cancer. | — |
Countries
Japan
Contacts
Public ContactChikatoshi Katada
Kitasato University School of Medicine Department of Gastroenterology
Outcome results
None listed