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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020354
Receipt No. R000023507
Official scientific title of the study A Prospective Observational Study on the Carbon Ion Therapy for Localized and Locally Advanced Prostate Cancer
Date of disclosure of the study information 2015/12/28
Last modified on 2017/06/05

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Basic information
Official scientific title of the study A Prospective Observational Study on the Carbon Ion Therapy for Localized and Locally Advanced Prostate Cancer
Title of the study (Brief title) A Prospective Observational Study on the Carbon Ion Therapy for Advanced Prostate Cancer (iROCK-PR01 Study)
Region
Japan

Condition
Condition Localized or locally advanced 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 Therapy for T1-T3N0M0 localized or locally advanced prostate cancer in Kanagawa cancer center.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Incidence of late-phase rectal adverse event with CTCAE Grade 2 or more
Key secondary outcomes 1) Incidence of early and late adverse events
2) 5-year biochemical and clinical recurrence
3) 5-year overall survival
4) Local control rate
5) ECOG Performance Status (PS)

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 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

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) Histologically proven primary prostate adenocarcinoma
2) cT1c,T2a,T2b,T2c,T3a,T3bN0M0
(2009, UICC 7th)
3) Performance status is 0, 1 or 2
4) Under 20 years old of age at registration
5) Untreated patient in 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
Key exclusion criteria 1) Past history of radiotherapy in the irradiation lesion concerned
2) Multiple active malignancies
3) Medically or psychologically inappropriate status for this study judged by physicians
Target sample size 12

Research contact person
Name of lead principal investigator Dr. Takuma Nomiya
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
Email tnomiya@kcch.jp

Public contact
Name of contact person Takuma Nomiya
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
Email tnomiya@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 Prefectual 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 神奈川県立病院機構
神奈川県立がんセンター
Kanagawa Cancer Center,
Kanagawa Prefectural Hospital Organization

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 28 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 10 Month 29 Day
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2026 Year 02 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Study Design: Single-arm prospective observational study
Subject Recruitment: Patients who visits Kanagawa Cancer Center during the registration period -i.e., from November to December 2015, and who fulfilling the inclusion and exclusion criteria

Management information
Registered date
2015 Year 12 Month 25 Day
Last modified on
2017 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023507


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