UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032199 |
|---|---|
| Receipt number | R000036720 |
| Scientific Title | A Retrospective Study for Mucosal Malignant Melanoma of the Head and Neck treated with Carbon-ion Radiotherapy Combined with DAV Chemotherapy |
| Date of disclosure of the study information | 2018/04/15 |
| Last modified on | 2020/10/12 10:02:23 |
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Basic information
Public title
A Retrospective Study for Mucosal Malignant Melanoma of the Head and Neck treated with Carbon-ion Radiotherapy Combined with DAV Chemotherapy
Acronym
Carbon-ion Radiotherapy Combined with DAV Chemotherapy for Mucosal Malignant Melanoma of the Head and Neck
Scientific Title
A Retrospective Study for Mucosal Malignant Melanoma of the Head and Neck treated with Carbon-ion Radiotherapy Combined with DAV Chemotherapy
Scientific Title:Acronym
Carbon-ion Radiotherapy Combined with DAV Chemotherapy for Mucosal Malignant Melanoma of the Head and Neck
Region
| Japan |
Condition
Condition
Mucosal Malignant Melanoma of the Head and Neck
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Carbon-ion radiotherapy combined with DAV chemotherapy for malignant melanoma of the head and neck.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control rate
Key secondary outcomes
Overall survival rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) histologically confirmed mucosal malignant melanoma of the head and neck, 2) N0M0, 3) inoperable tumor, 4) age between 15 and 80 years, 5) Performance status score <2, 6) grossly measurable tumor.
Key exclusion criteria
1) prior radiotherapy to the Carbon-ion radiotherapy treated area, 2) serious medical or psychological conditions precluding the safe administration of treatment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Takagi |
Organization
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Division name
Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3306
rtakagi@tdc.ac.jp
Public contact
Name of contact person
| 1st name | izumi |
| Middle name | |
| Last name | Kaneko |
Organization
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Scienc
Division name
Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku Chiba, Japan
TEL
043-206-3306
Homepage URL
helsinki@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
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
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Address
4-9-1 Anagawa, Inage-ku 263-8555 Chiba, Japan
Tel
043-206-3306
helsinki@qst.go.jp
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
| 2018 | Year | 04 | Month | 15 | 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
141
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subjects were treated in April 2001 to March 2016 in patients with mucosal malignant melanoma of the head and neck.
Management information
Registered date
| 2018 | Year | 04 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
