UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012414
Receipt No. R000014520
Scientific Title Phase II trial of carbon-ion radiotherapy for head and neck cancer(HIMAT1301)
Date of disclosure of the study information 2013/12/01
Last modified on 2013/11/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II trial of carbon-ion radiotherapy for head and neck cancer(HIMAT1301)
Acronym Phase II trial of carbon-ion radiotherapy for head and neck cancer(HIMAT1301)
Scientific Title Phase II trial of carbon-ion radiotherapy for head and neck cancer(HIMAT1301)
Scientific Title:Acronym Phase II trial of carbon-ion radiotherapy for head and neck cancer(HIMAT1301)
Region
Japan

Condition
Condition non-squamous cell carcinoma at head and neck region
Classification by specialty
Hematology and clinical oncology Ophthalmology Oto-rhino-laryngology
Radiology Oral surgery Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of carbon ion radiotherapy for head and neck cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3year local control rate
Key secondary outcomes overall survival rate
cause specific survival rate
normal tissue reaction

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 64GyE/16Fr/4weeks or 57.6GyE/16Fr/4weeks
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
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Non-squamous cell carcinoma with pathological diagnosis.
2)N0M0 or N1M0
3)Performance status:0-2
4)the patient with over 6months prognosis
5)other
Key exclusion criteria 1)with history of radiotherapy
2)under 2weeks after last chemotherapy
3)with another active cancer
4)with active infection
5)with metal material could not removed
6)other
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Shioyama
Organization Ion BeamTherapy Center,SAGA HIMAT Foundation
Division name radiology
Zip code
Address Harakogamachi415, Tosu-city, Jpn
TEL 0942-81-1897
Email yshioyama@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Suefuji
Organization Ion Beam Therapy Center,SAGA HIMAT Foundation
Division name radiology
Zip code
Address Harakogamachi415, Tosu-city, Jpn
TEL 0942-81-1897
Homepage URL
Email sufg@saga-himat.jp

Sponsor
Institute Ion Beam Therapy Center,SAGA HIMAT Foundation
Institute
Department

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
Address
Tel
Email

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
2013 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2013 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 27 Day
Last modified on
2013 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014520

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.