UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035093
Receipt number R000040005
Scientific Title An observational study to optimize first-line treatment for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan
Date of disclosure of the study information 2018/12/01
Last modified on 2022/01/21 23:13:49

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Basic information

Public title

An observational study to optimize first-line treatment for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan

Acronym

An observational study for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan

Scientific Title

An observational study to optimize first-line treatment for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan

Scientific Title:Acronym

An observational study for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan

Region

Japan


Condition

Condition

HPV related oropharyngeal carcinoma

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Among patients registered in the multicenter cancer registry of Japan, we will investigate the optimal treatment for human papilloma virus (HPV)-related oropharyngeal carcinoma taking into consideration the survival period and quality of life (QOL) according to clinical stages.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival period

Key secondary outcomes

Local progression-free survival period
Progression-free survival period
Proportion of nutritional support-free survival


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Presence of primary oropharyngeal neoplasm.
The neoplasm is pathologically confirmed as squamous cell carcinoma (SCC).
Histopathologically confirmed 75 % or more of the cancer tissue is p16-positive by immunostaining, irrespective of the assessment time.
Consent to participate in the present trial is obtained at the time of enrollment.
Patients with oropharyngeal cancer registered after 2011 in the multicenter cancer registry of Japan.

Key exclusion criteria

History of treatment for head and neck cancer.
Presence of active double cancer (synchronous double cancer, or metachronous double cancer with disease-free period of less than five years. However, lesions corresponding to carcinoma in situ, and mucosal carcinoma judged as cured by localized treatment will not be included as active double cancer)
When the attending physician judges participation in the present study to be unsuitable.

Target sample size

636


Research contact person

Name of lead principal investigator

1st name Katsunari
Middle name
Last name Yane

Organization

Nara Hospital Kindai University Faculty of Medicine

Division name

Otorhinolaryngology

Zip code

630-0293

Address

1248-1 Otoda-cho, Ikoma-shi, Nara prefecture

TEL

0743-77-0880

Email

kyane@med.kindai.ac.jp


Public contact

Name of contact person

1st name Katsunari
Middle name
Last name Yane

Organization

Nara Hospital Kindai University Faculty of Medicine

Division name

Otorhinolaryngology

Zip code

630-0293

Address

1248-1 Otoda-cho, Ikoma-shi, Nara prefecture

TEL

0743-77-0880

Homepage URL


Email

kyane@med.kindai.ac.jp


Sponsor or person

Institute

Japan Society for Head and Neck Cancer

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

Kindai University Nara Hospital

Address

1248-1 Otoda-cho, Ikoma-shi, Nara prefecture

Tel

0743-77-0880

Email

ikyokujimu@med.kindai.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

2018 Year 12 Month 01 Day


Related information

URL releasing protocol

https://center3.umin.ac.jp/umin-blog/edit/jshnc/?page_id=38#HPV

Publication of results

Published


Result

URL related to results and publications

https://center3.umin.ac.jp/umin-blog/edit/jshnc/?page_id=38#HPV

Number of participants that the trial has enrolled

688

Results

The patients were 558 males and 130 females. The results of the prognosis showed that the new TNM was able to predict prognoses appropriately in both OS and RSF. Findings regarding the treatment methods were as follows, the main method was chemoradiotherapy, and 200 mg.m2 CDDP dose was recommended, with a minimum dose of 160 mg.m2 showing benefit in Stage 1,2. In addition, for the patients having Stage 1,2, the results suggest that even radiotherapy alone can control the disease.

Results date posted

2020 Year 06 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 09 Month 15 Day

Baseline Characteristics

The subject sample includes patients with HPV-related oropharyngeal carcinoma who were registered in the multicenter cancer registry of Japan (HNC project) from 2011 onwards. Enrolment of patients already enrolled in other clinical investigations and clinical trials is also permitted.

Participant flow

The final number of registered institutions was 35, and the number of registered patients was 746, which far exceeded the targeted number of 636. After data cleaning, the number of patients became 714; after which patients meeting exclusion criteria, such as those who did not enter previous treatments and those on palliative treatment, were excluded and, ultimately, 688 patients were included in the final analysis set.

Adverse events

none

Outcome measures

1.1Primary outcome measure 
Overall survival period

1.2 Secondary outcome measure
Local progression-free survival period, progression-free survival period

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 07 Month 30 Day

Date of IRB

2017 Year 09 Month 11 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 05 Month 30 Day


Other

Other related information

For the patient background survey, first line treatment details survey, and prognosis survey, we will access the link only available for members on the Japan Society for Head and Neck Cancer's website, and log into the UMIN INDICE enrollment server with the password.


Management information

Registered date

2018 Year 12 Month 01 Day

Last modified on

2022 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040005


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name