UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012419 |
|---|---|
| Receipt number | R000014540 |
| Scientific Title | 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 20:48:25 |
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Basic information
Public title
PhaseII trial of carbon-ion radiotherapy with DAVFeron for head and neck melanoma. (HIMAT1302)
Acronym
PhaseII trial of carbon-ion radiotherapy with DAVFeron for head and neck melanoma. (HIMAT1302)
Scientific Title
PhaseII trial of carbon-ion radiotherapy with DAVFeron for head and neck melanoma. (HIMAT1302)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Shioyama |
Organization
Ion Beam Therapy Center, SAGA HIMAT Foundation
Division name
radiology
Zip code
Address
Harakogamachi415, Tosu-city, Jpn
TEL
0942-81-1897
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
sufg@saga-himat.jp
Sponsor or person
Institute
Ion Beam Therapy Center, SAGA HIMAT Foundation
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014540
