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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000038279 |
Receipt No. | R000043633 |
Scientific Title | Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer |
Date of disclosure of the study information | 2020/01/06 |
Last modified on | 2021/04/12 |
Basic information | ||
Public title | Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer | |
Acronym | Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer | |
Scientific Title | Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer | |
Scientific Title:Acronym | Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer | |
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 efficacy and safety of hypofractionated image-guided proton therapy for prostate cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The ratio of grade 2 or more acute genitourinary toxicity |
Key secondary outcomes | 5-year OS, bRFS, cRFS, bRF, cRF, Grade 2 or more late toxicity, QOL change |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
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 | image-guided proton therapy | |
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 and Female | |||
Key inclusion criteria | 1) histologically-confirmed prostate cancer
2) T1-T3bN0M0 3) ECOG-PS: 0-2 4) age: more than 20 years old 5) serious underlying disease or other cancers 6) capable of maintaining their position during irradiation 7) technically capable of proton therapy 8) written informed consent |
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Key exclusion criteria | 1)pathological specimen is not available to confirm the diagnosis
2)previous radiotherapy around the lesion 3)surgery for prostate cancer is performed prior to registration 4)active and uncontrolled infection 5)two or more anticoagulants and antiplatelets 6)bowel disease such as ulcerative colitis or postoperative rectal cancer 7)patients who cannot or refuse gold markers and Space OAR 8)serious complication 9)cases in which the doctor is judged inappropriate for medical or other reasons |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nagoya City University West Medical Center,Nagoya Proton Therapy Center | ||||||
Division name | Radiation oncology | ||||||
Zip code | 462-8508 | ||||||
Address | 1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture | ||||||
TEL | 052-991-8577 | ||||||
oginogio@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Nagoya City University West Medical Center,Nagoya Proton Therapy Center | ||||||
Division name | Radiation oncology | ||||||
Zip code | 462-8508 | ||||||
Address | 1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture | ||||||
TEL | 052-991-8577 | ||||||
Homepage URL | |||||||
h-iwa-ncu@nifty.com |
Sponsor | |
Institute | Nagoya City University West Medical Center |
Institute | |
Department |
Funding Source | |
Organization | Takeda Science Foundation |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Clinical Study Committees of the Nagoya City Hospital |
Address | 1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi-prefecture |
Tel | 052-721-7171 |
rinsho1@higashi-hosp.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 |
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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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
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=R000043633 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |