UMIN-CTR Clinical Trial

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

Superficial head and neck cancer

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

YES

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kitasato University School of Medicine, Department of Gastroenterology

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

12

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

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

Registered date

2019

Year

10

Month

11

Day

Last modified on

2020

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043627