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UMIN-CTR Clinical Trial |
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Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000020848 |
Receipt No. | R000024063 |
Official scientific title of the study | A phase II study on the carbon-ion radiotherapy for T1c-T3N0M0 localized prostate cancer |
Date of disclosure of the study information | 2016/02/03 |
Last modified on | 2018/04/13 |
Basic information | ||
Official scientific title of the study | A phase II study on the carbon-ion radiotherapy for T1c-T3N0M0 localized prostate cancer | |
Title of the study (Brief title) | Carbon-ion radiotherapy for localized prostate cancer (iROCK-1501PR) | |
Region |
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Condition | ||||
Condition | Localized prostate cancer | |||
Classification by specialty |
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Classification by malignancy | Malignancy | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safety and efficacy of the carbon ion radiotherapy for localized prostate cancer with clinical stage of T1c-T3N0M0 in Kanagawa Cancer Center |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Biochemical progression-free survival at 5 years |
Key secondary outcomes | 1) Overall survival
2) Disease-specific survival 3) Event-free survival 4) Early and late-phase adverse event rate |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Carbon-ion radiation therapy
A total of 51.6GyE consisting of 12 fractions; once a day 4.3 GyE, 6-8 times for 2 weeks |
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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 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male | |||
Key inclusion criteria | 1) Histologically confirmed primary prostate adenocarcinoma
2) cT1c,T2a,T2b,T2c,T3a,T3b,N0M0, in accordance with UICC 7th (2009) 3) ECOG Performance status is 0, 1 or 2 4) Over 20 of age at registration 5) Untreated patient for prostate cancer, excluding Neoadjuvant endocrine therapy 6) Patients are informed for diagnosis of prostate cancer and independently agree with this study on carbon-ion radiotherapy |
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Key exclusion criteria | 1) Patient with past history of radiotherapy for the targeted lesion
2) Patient with castration-resistant prostate cancer 3) Patient with active double cancer 4) Patients with active and intractable infection in the targeted lesion. 5) Patient with metal devices in the lesion 6) Other medical or psychological condition which is unsuitable for carbon-ion therapy |
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Target sample size | 145 |
Research contact person | |
Name of lead principal investigator | Dr. Hiroyuki Katoh |
Organization | Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization |
Division name | Department of Carbon-ion Radiotherapy |
Address | 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture |
TEL | 045-520-2222 |
hkatoh@kcch.jp |
Public contact | |
Name of contact person | Dr. Hiroyuki Katoh |
Organization | Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization |
Division name | Ion-beam Radiation Oncology Center |
Address | 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture |
TEL | 045-520-2222 |
Homepage URL | |
hkatoh@kcch.jp |
Sponsor | |
Institute | Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
Funding Source | |
Organization | Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | None |
Name of secondary funder(s) | None |
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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Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information |
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=R000024063 |