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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012373
Receipt No. R000014461
Official scientific title of the study A phase II clinical trial of carbon-ion radiotherapy for patients with bone and soft tissue sarcomas not suited for surgical resection(HIMAT1341)
Date of disclosure of the study information 2013/12/01
Last modified on 2014/04/24

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Basic information
Official scientific title of the study A phase II clinical trial of carbon-ion radiotherapy for patients with bone and soft tissue sarcomas not suited for surgical resection(HIMAT1341)
Title of the study (Brief title) Carbon-ion radiotherapy for bone and soft tissue sarcomas (HIMAT1341)
Region
Japan

Condition
Condition bone and soft tissue sarcomas not suited for surgical resection
Classification by specialty
Orthopedics Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of carbon-ion radiotherapy for bone and soft tissue sarcomas not suited for surgical resection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes two year local control rate
Key secondary outcomes survival rate, progression free survival, complication rate

Base
Study type

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
Other
Interventions/Control_1 Carbon-ion radiotherapy
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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histolocgically proven primary bone and soft tissue sarcomas
2) Unresectable tumor or patient's refusal of surgery
3) Not exceeding 15cm in tumor size
4) Measurable tumor
5) Age between 16 and 80 years old
6) PS 0-3
7) No distant metastasis
8) Expected to survival more than 6 months
9) Informed consent by patient
Key exclusion criteria 1) Located in Head
2) Past history of irradiation to the target
3) Past history of chemotherapy within 2 weeks before treatment
4) Active double cancers
5) Uncontrolled infectious disease
6) Artifact affecting dose calculation
7) Other medical or psychological unsuitable reasons
Target sample size 40

Research contact person
Name of lead principal investigator Yoshiyuki Shioyama
Organization SAGA HIMAT Foundation
Division name Ion Bean Therapy Center
Address 415, Harakoga-machi, Tosu, Saga, 841-0077
TEL 0942-81-1897
Email shioyama-yoshiyuki@saga-himat.jp

Public contact
Name of contact person Makoto Shinoto
Organization SAGA HIMAT Foundation
Division name Ion Bean Therapy Center
Address 415, Harakoga-machi, Tosu, Saga, 841-0077
TEL 0942-81-1897
Homepage URL
Email shinoto@saga-himat.jp

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

Funding Source
Organization No
Organization
Division
Category of Funding Organization Non profit foundation
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 Open public recruiting
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 Prospective study

Management information
Registered date
2013 Year 11 Month 21 Day
Last modified on
2014 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014461

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
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