Phase II and III Studies of Transoral Surgery for Superficial Head and Neck Cancer

Phase 2

Recruiting

• Conditions: Superficial Head and Neck Cancer

• Registration Number: JPRN-UMIN000026682
• Lead Sponsor: Kitasato University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.