UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033007
Receipt number R000037631
Scientific Title Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers
Date of disclosure of the study information 2018/06/16
Last modified on 2019/06/04 12:20:42

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Basic information

Public title

Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers

Acronym

Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers

Scientific Title

Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers

Scientific Title:Acronym

Study of efficacy and safety of dose reduction in the oral cavity by target volume definition using PET/CT for intensity-modulated radiation therapy of head and neck cancers

Region

Japan


Condition

Condition

Head-and-neck cancer

Classification by specialty

Oto-rhino-laryngology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of determining the target volume using PET/CT, which allows imaging at the posture assumed at the time of radiation therapy, when planning an intensity-modulated radiation treatment for head and neck cancer patients whose lesions extend to the level of the oral cavity.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The target volume (at the oral cavity level) defined by PET/CT and the radiation dose in the oral cavity

Key secondary outcomes

Acute and late adverse events during and after the radiation therapy
The presence or absence of local recurrence and distant metastasis during the 3-year post-treatment period, and overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Patients whose target volume is defined by PET/CT and in whom radiation therapy is performed according to the defined planning target volume

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with head neck cancer who meet all of the following criteria;
1.Age over 20
2.Pathologically confirmed head neck cancer
3.The neck (at the oral cavity level) will be irradiated with a dose of 50Gy or higher
4.Performance status (ECOG) 0-2
5.Written informed consent

Key exclusion criteria

1.Patients have psychiatric disorders that may comprise the patient's ability to receive radiotherapy
2.Patients who is considered ineligible for enrolling the study by a principal investigator or sub-investigator

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Sasai
Middle name
Last name Keisuke

Organization

Juntendo University

Division name

Department of Radiation Oncology

Zip code

113-8431

Address

Tokyo

TEL

+81338133111

Email

ykosugi@juntendo.ac.jp


Public contact

Name of contact person

1st name Kosugi
Middle name
Last name Yasuo

Organization

Juntendo University

Division name

Department of Radiation Oncology

Zip code

113-8431

Address

Tokyo

TEL

+81338133111

Homepage URL


Email

ykosugi@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University,Graduate School of Medicine,Department of Radiation Oncology

Institute

Department

Personal name



Funding Source

Organization

Juntendo University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo Clinical Research and Trial Center

Address

3-1-3 hongo,Bunkyo,Tokyo

Tel

03-5802-1584

Email

kenkyu58585@juntendo.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 06 Month 16 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

2018 Year 03 Month 05 Day

Date of IRB

2018 Year 05 Month 31 Day

Anticipated trial start date

2018 Year 06 Month 15 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 15 Day

Last modified on

2019 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037631


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name