UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027640 |
|---|---|
| Receipt number | R000031664 |
| Scientific Title | A Prospective Clinical Trial of Carbon-ion Radiotherapy for Patients with Prostate Cancer of Clinical Stage T1c-T3N0M0 |
| Date of disclosure of the study information | 2017/06/06 |
| Last modified on | 2023/12/27 09:29:19 |
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Basic information
Public title
A Prospective Clinical Trial of Carbon-ion Radiotherapy for Patients with Prostate Cancer of Clinical Stage T1c-T3N0M0
Acronym
Carbon-ion Radiotherapy for T1c-T3N0M0 Prostate Cancer (iROCK-1701PR)
Scientific Title
A Prospective Clinical Trial of Carbon-ion Radiotherapy for Patients with Prostate Cancer of Clinical Stage T1c-T3N0M0
Scientific Title:Acronym
Carbon-ion Radiotherapy for T1c-T3N0M0 Prostate Cancer (iROCK-1701PR)
Region
| Japan |
Condition
Condition
Patients with Prostate Cancer of Clinical Stage T1c-T3N0M0
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the carbon ion radiotherapy for prostate cancer 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
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
| Device,equipment |
Interventions/Control_1
Carbon-ion radiation therapy
A total of 51.6Gy(RBE) consisting of 12 fractions; once a day 4.3 Gy(RBE), 6-8 times for 2 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed primary prostate adenocarcinoma
2) Either clinical stage of T1c, T2a, T2b, T2c, T3a, or T3b and N0M0, in accordance with UICC 7th (2009)
3) ECOG Performance status is 0, 1 or 2
4) Twenty years old of age at registration or more
5) Untreated patient for prostate cancer, except for those who undergo 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) Patient with past history of radiotherapy for the targeted lesion
2) Patient with castration-resistant prostate cancer
3) Patient with active double cancer
4) Patient with active and intractable infection in the targeted lesion.
5) Patient with metal devices in the lesion which will cause adverse risk by carbon-ion radiotherapy
6) Patient eligible for Advanced Medicine Program B (Sen-shin Iryo B)
7) Other medical or psychological condition which is unsuitable for carbon-ion therapy
Target sample size
689
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Department of Carbon-ion Radiotherapy
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
hkatoh@kcch.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Center for Carbon-ion Radiotherapy
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
Homepage URL
hkatoh@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department
Personal name
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
IRB Contact (For public release)
Organization
Kanagawa Cancer Center IRB
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
Tel
045-520-2222
clinical_trials@kcch.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
| 2017 | Year | 06 | Month | 06 | 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
78
Results
This study confirmed safety and efficacy comparable to those reported from prior facilities.
Results date posted
| 2023 | Year | 12 | Month | 27 | Day |
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
| 2017 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031664
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