UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II and III Studies of Transoral Surgery for Superficial Head and Neck Cancer
Title of the study (Brief title)	TOS-J trial (Phase II/III Study of Transoral Surgery for Superficial Head and Neck Cancer in Japan)
Region	Japan

Condition
Condition	Superficial Head and Neck Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The study group comprised 568 of the 599 patients (959 lesions) who were registered in the National Registration Survey of Superficial Head and Neck Cancer. The median follow-up was 46.1 months (range, 1.1 to 113.3). The overall survival rate at 3 years was 87.9%, which was considered good. Adverse events occurred in 12.2% of 768 treatment sessions, among which 0.9% were life-threatening, but there was no treatment-related death. The present intervention trial is designed to study the effectiveness and safety of transoral surgery for superficial head and neck cancer on the basis of these results. In the present study, the safety of transoral surgery will be evaluated in a phase II study. After confirming the safety of treatment, a validation phase III study will be performed.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	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
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Transoral surgery for superficial head and neck cancer
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key 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.
Key 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)
Target sample size	130

Research contact person
Name of lead principal investigator	Ryuichi Hayashi
Organization	National cancer center hospital east
Division name	Department of Head and Neck Surgery
Address	Kashiwanoha 6-5-1, Kashiwa, Chiba 277-8577, Japan
TEL	0471-33-1111
Email	rhayashi@east.ncc.go.jp

Public contact
Name of contact person	Chikatoshi Katada
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Address	Kitasato 1-15-1, Minami, Sagamihara, Kanagawa 252-0374, Japan
TEL	042-778-8111
Homepage URL
Email	ckatada@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 14 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 24 Day
Last modified on	2017 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030638