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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | |||
Condition | castration refractory prostate cancer | ||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Gunma University | ||||||
Division name | Urology | ||||||
Zip code | |||||||
Address | 3-39-22 Showa-machi, Maebashi | ||||||
TEL | (027)220-8300 | ||||||
kazu@gunma-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Gunma University | ||||||
Division name | Heavy ion medical center | ||||||
Zip code | |||||||
Address | 3-39-22 Showa-machi, Maebashi | ||||||
TEL | 027-220-8378 | ||||||
Homepage URL | |||||||
kawa@gunma-u.ac.jp |
Sponsor | |
Institute | Working group of heavy ion therapy for genitourinary tumor, Gunma university
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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 | |
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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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |