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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016763
Receipt No. R000019421
Scientific Title Efficacy study of the carbon ion radiotherapy in 16 fractions for castration refractory prostate cancer
Date of disclosure of the study information 2015/03/15
Last modified on 2017/03/11

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Basic information
Public title Efficacy study of the carbon ion radiotherapy in 16 fractions for castration refractory prostate cancer
Acronym GUNMA1103
Scientific Title Efficacy study of the carbon ion radiotherapy in 16 fractions for castration refractory prostate cancer
Scientific Title:Acronym GUNMA1103
Region
Japan

Condition
Condition castration refractory prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy of the carbon ion radiotherapy in 16 fractions for non-metastatic castration refractory prostate cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5-yr biochemical relapse free survival
Key secondary outcomes 1) 5-yr overall survival
2) 5-yr cause specific survival
3) 5-yr local control
4) acute toxicity
5) late toxicity
6) QOL

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria 1) Continuous PSA increase in spite of castration level of testosterone.
2) Histologically proven primary prostate adenocarcinoma
3) Gleason score is diagnosed
4) T1c-T3N0M0(2009, UICC 7th)
5) PSA value before biopsy and before this study are measured
6) No lymph node and distant metastasis
7) Age at registration is 20-80
8) Performance status is 0-2
9) Diagnosis is informed
10) Having the ability to consent
Key exclusion criteria 1) Past radiotherapy to the pelvic region
2) Past physical treatment of the prostate (TUR-P, HIFU, etc.)
3) Past chemotherapy within 4 weeks
4) Life expectancy is less than 6 months
5) Multiple malignancies within 5 years
6) Severe comorbidity
7) Judged inappropriate for this study by physicians
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Suzuki
Organization Gunma University
Division name Urology
Zip code
Address 3-39-22 Showa-machi, Maebashi
TEL (027)220-8300
Email kazu@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidemasa Kawamura
Organization Gunma University
Division name Heavy ion medical center
Zip code
Address 3-39-22 Showa-machi, Maebashi
TEL 027-220-8378
Homepage URL
Email kawa@gunma-u.ac.jp

Sponsor
Institute Working group of heavy ion therapy for genitourinary tumor, Gunma university
Institute
Department

Funding Source
Organization Gunma University
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
Email

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
2015 Year 03 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
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 Terminated
Date of protocol fixation
2013 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 04 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 Check the symptoms, laboratory tests, radiological tests and QOL scores periodically.

Management information
Registered date
2015 Year 03 Month 10 Day
Last modified on
2017 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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