UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034858
Receipt number R000039746
Scientific Title Retrospective study of carbon-ion radiotherapy for malignant tumor of sphenoid sinus
Date of disclosure of the study information 2018/11/11
Last modified on 2019/05/20 18:03:31

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Basic information

Public title

Retrospective study of carbon-ion radiotherapy for malignant tumor of sphenoid sinus

Acronym

Carbon-ion radiotherapy for malignant tumor of sphenoid sinus

Scientific Title

Retrospective study of carbon-ion radiotherapy for malignant tumor of sphenoid sinus

Scientific Title:Acronym

Carbon-ion radiotherapy for malignant tumor of sphenoid sinus

Region

Japan


Condition

Condition

Malignant tumor of sphenoid sinus

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of carbon-ion radiotherapy for malignant tumor of sphenoid sinus

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival
Local control
Late toxicity

Key secondary outcomes



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

Diagnosed as malignant tumor fo sphenoid sinus.
Case of Carbon-ion radiotherapy.

Key exclusion criteria

Case of post-operative irradiation.
Case of Carbon-ion radiotherapy for recurrence.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yasuhito
Middle name
Last name Hagiwara

Organization

National Institutes for Quantum and Radiological Sciences and Technology

Division name

Hospital of the National Institute of Radiological Sciences

Zip code

263-8555

Address

Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan

TEL

043-206-3360

Email

hagiwara.yasuhito@gmail.com


Public contact

Name of contact person

1st name Yasuhito
Middle name
Last name Hagiwara

Organization

National Institutes for Quantum and Radiological Sciences and Technology

Division name

Hospital of the National Institute of Radiological Sciences

Zip code

263-8555

Address

Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan

TEL

043-206-3360

Homepage URL


Email

hagiwara.yasuhito@gmail.com


Sponsor or person

Institute

National Institutes for Quantum and Radiological Sciences and Technology

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Institutes for Quantum and Radiological Science and Technology Certified Review Board

Address

Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan

Tel

043-206-4706

Email

helsinki@qst.go.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 11 Month 11 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

22

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

Completed

Date of protocol fixation

2018 Year 10 Month 15 Day

Date of IRB

2018 Year 10 Month 15 Day

Anticipated trial start date

2018 Year 11 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2018 Year 11 Month 11 Day

Last modified on

2019 Year 05 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039746


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name