UMIN-CTR Clinical Trial

Basic information
Public title	A Multicenter Prospective Cohort Study in Patients who Undergo Transoral Surgery for Superficial Head and Neck Cancer
Acronym	TOS-J 2 trial
Scientific Title	A Multicenter Prospective Cohort Study Assessing the Effect of the Early Detection of Metachronous Cancers Arising in Other Organs on Outcomes, Risk Factors, and Prevention in Patients who Undergo Transoral Surgery for Superficial Head and Neck Cancer
Scientific Title:Acronym	A multicenter prospective cohort study after TransOral Surgery for superficial head and neck cancer in Japan 2: TOS-J 2 trial
Region	Japan

Condition
Condition	Superficial head and neck cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	A nationwide registration survey of superficial head and neck cancer demonstrated that many of such patients have metachronous cancers arising in other organs and died of such cancers after transoral surgery (TOS). Whether superficial head and neck cancer can be curatively treated by TOS is an important issue because it involves outcomes. We therefore conducted comprehensive surveillance after TOS to examine the incidence of metachronous cancers arising in other organs and performed a prospective cohort study to examine whether comprehensive surveillance can contribute to the early detection of metachronous cancers and thereby improve outcomes and to investigate the relation between the cessation of drinking and smoking and the development of metachronous cancers, and risk factors for the development of metachronous cancers.
Basic objectives2	Others
Basic objectives -Others	Cohort study
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	80 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	273

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Muto
Organization	Kyoto University Hospital
Division name	Department of Clinical Oncology
Zip code	606-8507
Address	54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-4592
Email	mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Chikatoshi Middle name Last name Katada
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0375, Japan
TEL	042-778-8111
Homepage URL
Email	ckatada@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine, Department of Gastroenterology
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)

IRB Contact (For public release)
Organization	IRB of Kitasato University Hospital
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0375, Japan
Tel	042-778-8273
Email	rinrib@med.kitasato-u.ac.jp

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	2019 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 10 Month 24 Day
Date of IRB	2019 Year 11 Month 21 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2033 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	At study entry, patients will be instructed to abstain from smoking and drinking alcohol.

Management information
Registered date	2019 Year 10 Month 11 Day
Last modified on	2020 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043627