UMIN-CTR Clinical Trial

Public title

National registration survey of superficial head and neck cancer

Acronym

National registration survey of superficial head and neck cancer

Scientific Title

National registration survey of superficial head and neck cancer

Scientific Title:Acronym

National registration survey of superficial head and neck cancer

Region

Japan

Condition

head and neck cancer

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To conduct a national survey of the following items in patients with transorally resected superficial head and neck cancer.

1. Survey of clinical and histopathological characteristics of superficial head and neck cancer
2. Survey of outcomes including overall survival, disease-free survival, relapse-free survival, metastatic relapse-free survival, and cause-specific survival
3. Rates of local failure and recurrence
4. Rates of lymph-node and distant metastases
5. Incidence of metachronous cancer
6. Incidence of second primary cancer
7. Evaluation of risk factors for local failure, relapse, and metastatic relapse
8. Survey of adverse events associated with treatment
9. Rate of organ preservation

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. Survey of clinical and histopathological characteristics of superficial head and neck cancer
2. Survey of outcomes including overall survival, disease-free survival, relapse-free survival, metastatic relapse-free survival, and cause-specific survival
3. Rates of local failure and recurrence
4. Rates of lymph-node and distant metastases
5. Incidence of metachronous cancer
6. Incidence of second primary cancer
7. Evaluation of risk factors for local failure, relapse, and metastatic relapse
8. Survey of adverse events associated with treatment
9. Rate of organ preservation

Key secondary outcomes

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histologically confirmed squamous-cell carcinoma (including high-grade intraepithelial neoplasia)
2. Histologically confirmed superficial head and neck cancer
3. Transoral resection was performed by December 2009 (irrespective of the presence or absence of additional treatment)
4. A tumor-negative vertical margin of the resected specimen
5. Lesions localized to the oropharynx/hypopharynx or supraglottis (including lesions partially involving the cervical esophagus)
6. No clinical evidence of lymph-node metastasis
7. The absence of active advanced head and neck cancer (patients with metachronous multiple cancer after surgery or chemoradiotherapy can be enrolled)

Key exclusion criteria

Patients judged by their attending physician to be unsuitable for enrollment

Target sample size

250

Name of lead principal investigator

1st name
Middle name
Last name	Manabu Muto

Organization

Graduate School of Medicine Kyoto University

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

54 Shogoinkawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.

TEL

Email

Name of contact person

1st name
Middle name
Last name	Chikatoshi Katada

Organization

Kitasato University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan

TEL

Homepage URL

Email

Institute

Kitasato University School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2012

Year

06

Month

27

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

2012

Year

05

Month

11

Day

Date of IRB

Anticipated trial start date

2012

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Retrospective cohort study

Registered date

2012

Year

06

Month

27

Day

Last modified on

2012

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009520