UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007903 |
|---|---|
| Receipt number | R000009307 |
| Scientific Title | Efficacy and safety of carbon ion radiotherapy for primary skull base tumor |
| Date of disclosure of the study information | 2012/05/07 |
| Last modified on | 2015/01/08 21:08:53 |
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Basic information
Public title
Efficacy and safety of carbon ion radiotherapy for primary skull base tumor
Acronym
carbon ion radiotherapy for skull base tumor
Scientific Title
Efficacy and safety of carbon ion radiotherapy for primary skull base tumor
Scientific Title:Acronym
carbon ion radiotherapy for skull base tumor
Region
| Japan |
Condition
Condition
Primary skull base tumor
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of 16 fractionated carbon ion radiotherapy for primary skull base tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control rate at 3 years
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically or radiologicaly proven primary skull base tumor
2. Without lymph node and/or distant metastasis
3. Measureable tumor
4. Age between 16 and 80 years old
5. PS 0-3
6. Life expectancy more than 6 months
7. Informed consent
Key exclusion criteria
1. Obvious tumor invasion to central nervous system
2. Past history of chemotherapy within 4 weeks before treatment
3. Uncontrolled infectious disease
4. Past history of irradiation to the target
5. Uncontrolled severe complication
6. Active double cancers
7. In pregnancy or during the lactation period
8. Other medical or psychological unsuitable reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511
TEL
027-220-8383
tnakano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ei Noda |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511
TEL
027-220-8378
Homepage URL
http://heavy-ion.showa.gunma-u.ac.jp/index.php
gunmaciru-office@umin.ac.jp
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
群馬大学重粒子線医学研究センター
Gunma University Heavy Ion Medical Center
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 07 | 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
| 2012 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2012 | Year | 05 | Month | 07 | Day |
Last modified on
| 2015 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009307
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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