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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007903
Receipt No. R000009307
Official scientific title of the study 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

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Basic information
Official scientific title of the study Efficacy and safety of carbon ion radiotherapy for primary skull base tumor
Title of the study (Brief title) 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 Takashi Nakano
Organization Gunma University
Division name Gunma University Heavy Ion Medical Center
Address 3-39-22 Showa, Maebashi, Gunma 371-8511
TEL 027-220-8383
Email tnakano@gunma-u.ac.jp

Public contact
Name of contact person Shin-ei Noda
Organization Gunma University
Division name Gunma University Heavy Ion Medical Center
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
Email gunmaciru-office@umin.ac.jp

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2012 Year 03 Month 28 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009307

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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