Unique ID issued by UMIN | UMIN000021517 |
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Receipt number | R000024815 |
Scientific Title | Phase II Clinical Trial of Carbon-Ion Radiotherapy with Longer Hormone Therapy for Clinical Stage T1b-T3N0M0 Prostate Cancer |
Date of disclosure of the study information | 2016/03/18 |
Last modified on | 2023/12/25 16:38:16 |
Phase II Clinical Trial of Carbon-Ion Radiotherapy with Longer Hormone Therapy for Clinical Stage T1b-T3N0M0 Prostate Cancer
Extended Study of Carbon-Ion Radiotherapy for Prostate Cancer
Phase II Clinical Trial of Carbon-Ion Radiotherapy with Longer Hormone Therapy for Clinical Stage T1b-T3N0M0 Prostate Cancer
Extended Study of Carbon-Ion Radiotherapy for Prostate Cancer
Japan |
Localized prostate cancer
Surgery in general | Urology | Radiology |
Malignancy
NO
To evaluate the safety and efficacy of the carbon ion radiotherapy with longer hormone therapy for localized or locally advanced prostate cancer in Kanagawa Cancer Center
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Biochemical progression-free survival at 5 years
1) Overall survival, Disease-specific survival
2) Local recurrence-free survival
3) Early and late-phase adverse event rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
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
20 | years-old | <= |
Not applicable |
Male
1) Histologically confirmed primary prostate adenocarcinoma
2) Clinical stage of T1b, T1c, T2a, T2b, T2c, T3a or T3b and N0 M0, in accordance with UICC 7th (2009)
3) ECOG Performance status is 0, 1 or 2
4) Twenty years or older of the 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
1) Patient with past history of radiotherapy for the targeted lesion
2) Patient with active double cancer
3) Patient with hormone-resistant prostate 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
145
1st name | Hiroyuki |
Middle name | |
Last name | Katoh |
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Department of Carbon-ion Radiotherapy
241-8515
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
hkatoh@kcch.jp
1st name | Hiroyuki |
Middle name | |
Last name | Katoh |
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Ion-beam Radiation Oncology Center
241-8515
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
hkatoh@kcch.jp
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Self funding
Japan
None
None
Kanagawa Cancer Center IRB
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
045-520-2222
clinical_trials@kcch.jp
NO
神奈川県立がんセンター(神奈川県)
2016 | Year | 03 | Month | 18 | Day |
Unpublished
40
This study confirmed safety and efficacy comparable to those reported from prior facilities.
2023 | Year | 12 | Month | 25 | Day |
Completed
2016 | Year | 03 | Month | 15 | Day |
2016 | Year | 03 | Month | 15 | Day |
2016 | Year | 03 | Month | 15 | Day |
2028 | Year | 03 | Month | 31 | Day |
2028 | Year | 03 | Month | 31 | Day |
2028 | Year | 03 | Month | 31 | Day |
2029 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 17 | Day |
2023 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024815
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