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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012419
Receipt No. R000014540
Official scientific title of the study PhaseII trial of carbon-ion radiotherapy with DAVFeron for head and neck melanoma. (HIMAT1302)
Date of disclosure of the study information 2013/12/01
Last modified on 2013/11/27

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Basic information
Official scientific title of the study PhaseII trial of carbon-ion radiotherapy with DAVFeron for head and neck melanoma. (HIMAT1302)
Title of the study (Brief title) PhaseII trial of carbon-ion radiotherapy with DAVFeron for head and neck melanoma. (HIMAT1302)
Region
Japan

Condition
Condition malignant melanoma of head and neck
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 with DAVFeron for head and neck melanoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3year overall and cause-specific survival rate
Key secondary outcomes loral control 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 C-RT:64GyE/16fraction(GTV over 40cc), 57.6GyE/16fraction(GTV under 40cc).
Chemotherapy:DAVFeron
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)malignant melanoma with pathological diagonosis of head and neck.
2)hepatic, cardiac, and renal function are in tolerance level.
3)Performance status:0-2
4)the patient with over 6months prognosis
5)other
Key exclusion criteria 1)with history of radiotherapy
2)with another active cancer
3)with active infection
4)with metal material could not be removed
5)other
Target sample size 25

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

Public contact
Name of contact person Hiroaki Suefuji
Organization Ion Beam Therapy Center, SAGA HIMAT Foundation
Division name radiology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2013 Year 08 Month 26 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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=R000014540

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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