Superficial head and neck cancer
Conditions
Interventions
None listed
Sponsors
Kitasato University School of Medicine, Department of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who underwent TOS for superficial head and neck cancer (those who underwent TOS as initial or previous treatment) 2) The most common site of lesion was the oropharynx, the hypopharynx, or the supraglottic 3) Complete endoscopic resection 4) Histopathologically diagnosed squamous cell carcinoma in resected specimens 5) Tumor-negative vertical margins of resected specimens 6) No evidence of nodal or distant metastasis (cN0M0) on contrast-enhanced computed tomography of the neck, the chest, and the abdomen (Regions including the cranial base should be scanned. However, if not possible, plain computed tomography is acceptable.) 7) Patients who do not receive additional treatment (such as surgical resection, radiotherapy, and chemotherapy) after TOS 8) An age between 20 years or older and 80 years or younger at the time of registration 9) Patients evaluated by their attending physicians to be in good general condition, allowing at least 10 years of follow-up 10) Written informed consent from the patient
Exclusion criteria
Exclusion criteria: 1) Patients who were enrolled in the JEC-1 study, the JEC-2 study, or the TOS-J study 2) Patients with active synchronous cancers arising in other organs (However, intramucosal carcinomas in other organs were not handled as active cancers arising in other organs.) 3) Patients who were judged to be ineligible by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative incidence of metachronous cancers arising in other organs The endpoint was evaluated after the final enrolled patients were followed up for 2, 5, and 10 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The total number of metachronous cancers arising in other organs per 100 person-years 2) The cumulative incidence of metachronous head and neck cancers 3) The total number of metachronous head and neck cancers per 100 person-years 4) The relation between the cessation of drinking and smoking and the development of metachronous cancers 5) Risk factors for the development of metachronous cancers 6) The outcomes of enrolled patients 7) Enrolled patients in our study were comprehensively compared with those in previous studies (the JEC-1, JEC-2, and TOS-J studies) to examine the incidence of metachronous cancers, the preventive effect of cessation of drinking and smoking, associated risk factors, and outcomes. These endpoints were evaluated after the final enrolled patients were followed up for 2, 5, and 10 years. | — |
Countries
Japan
Contacts
Public ContactChikatoshi Katada
Kitasato University School of Medicine Department of Gastroenterology
Outcome results
None listed