UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038275
Receipt number R000043627
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
Date of disclosure of the study information 2019/12/31
Last modified on 2020/10/29 14:47:18

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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 or person

Institute

Kitasato University School of Medicine, Department of Gastroenterology

Institute

Department

Personal name



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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name