UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016646 |
|---|---|
| Receipt number | R000019300 |
| Scientific Title | Prospective observational safety and efficacy study of the carbon ion radiotherapy in 16 fractions for localized prostate cancer |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2022/03/03 10:07:48 |
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Basic information
Public title
Prospective observational safety and efficacy study of the carbon ion radiotherapy in 16 fractions for localized prostate cancer
Acronym
GUNMA1302
Scientific Title
Prospective observational safety and efficacy study of the carbon ion radiotherapy in 16 fractions for localized prostate cancer
Scientific Title:Acronym
GUNMA1302
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of the carbon ion radiotherapy in 16 fractions for T1c-T3N0M0 prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
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) Histologically proven primary prostate adenocarcinoma
2) Gleason score is diagnosed
3) T1c-T3N0M0(2009, UICC 7th)
4) PSA value before biopsy is measured
5) Age at registration is 20-80
6) Performance status is 0-2
7) Diagnosis is informed
8) 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) Androgen deprivation therapy period will be over than 8 months at the end of carbon ion radiotherapy
7) Castration refractory
8) Denial for the protocol androgen deprivation therapy
9) Steroid and anti-androgen therapy for other disease
10) Severe comorbidity
11) Judged inappropriate for this study by physicians
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
Gunma University
Division name
Urology
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi
TEL
(027)220-8300
kazu@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Kawamura |
Organization
Gunma University
Division name
Heavy ion medical center
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi
TEL
027-220-8378
Homepage URL
kawa@gunma-u.ac.jp
Sponsor or person
Institute
working group of heavy ion therapy for genitourinary tumor, Gunma university
Institute
Department
Personal name
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
Gunma University Hospital IRB
Address
3-39-22 Showa-machi, Maebashi
Tel
027-220-8740
gunmaciru-office@umin.ac.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
| 2015 | Year | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
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 | 02 | Month | 26 | Day |
Last modified on
| 2022 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019300
