UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012373 |
|---|---|
| Receipt number | R000014461 |
| Scientific Title | 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 | 2018/10/24 17:21:48 |
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Basic information
Public title
A phase II clinical trial of carbon-ion radiotherapy for patients with bone and soft tissue sarcomas not suited for surgical resection(HIMAT1341)
Acronym
Carbon-ion radiotherapy for bone and soft tissue sarcomas (HIMAT1341)
Scientific Title
A phase II clinical trial of carbon-ion radiotherapy for patients with bone and soft tissue sarcomas not suited for surgical resection(HIMAT1341)
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Shioyama |
Organization
SAGA HIMAT Foundation
Division name
Ion Bean Therapy Center
Zip code
Address
415, Harakoga-machi, Tosu, Saga, 841-0077
TEL
0942-81-1897
shioyama-yoshiyuki@saga-himat.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Terashima Kotaro |
Organization
SAGA HIMAT Foundation
Division name
Ion Bean Therapy Center
Zip code
Address
415, Harakoga-machi, Tosu, Saga, 841-0077
TEL
0942-81-1897
Homepage URL
terashima-kotaro@saga-himat.jp
Sponsor or person
Institute
Ion Bean Therapy Center, SAGA HIMAT Foundation
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Open public recruiting
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
Prospective study
Management information
Registered date
| 2013 | Year | 11 | Month | 21 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014461
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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