Unique ID issued by UMIN | UMIN000010236 |
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Receipt number | R000011982 |
Scientific Title | Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer |
Date of disclosure of the study information | 2013/04/01 |
Last modified on | 2019/09/17 10:49:56 |
Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Japan |
low risk prostate cancer
Urology | Radiology |
Malignancy
NO
To identify the maximum tolerated dose (MTD) and recommended dose (RD) for one fraction of hypofractionated intensity modulated radiotherapy with 4 fractions.
Safety
Confirmatory
Pragmatic
Phase I
maximum tolerated dose and recommended dose
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Radiotherapy
20 | years-old | <= |
Not applicable |
Male
*T2b or lower
*No lymph node metastasis
*No distant metastasis
*initial PSA=10ng/ml or lower
*Gleason Score=4+3 or lower
*20 years old or older
*Performance status (ECOG) 0 or 1
*No history of radiotherpay, chemotherapy, and hormonal therapy
*Normal organ function
*Infromed consent in writing
*Other malignant tumors within 5 years except for carcinoma in situ
*Psychiatric disease
*Long-term administration of steroidal drugs
*Poorly-controlled diabetis (HbA1c=6.5% or more)
*Active infectious disease
*Cerebral apoplexy within 6 months
27
1st name | |
Middle name | |
Last name | Kazushige Hayakawa |
Kitasato university school of medicine
Radiology and Radiation Oncology
1-15-1 Kitasato, Sagamiharashiminamiku, Kanagawa, Japan
042-778-8453
hayakazu@med.kitasato-u.ac.jp
1st name | |
Middle name | |
Last name | Hiromichi Ishiyama |
Kitasatoo university school of medicine
Radiology and Radiation Oncology
1-15-1 Kitasato, Sagamiharashi-minamiku, kanagawa Japan
042-778-8453
hishiyam@kitasato-u.ac.jp
Kitasato univeristy school of medicine
none
Other
NO
2013 | Year | 04 | Month | 01 | Day |
https://www.ncbi.nlm.nih.gov/pubmed/31477122
Published
https://www.ncbi.nlm.nih.gov/pubmed/31477122
27
Nine patients were enrolled in each level. All patients were low or intermediate risk. Median durations of follow-up for patients at levels 1-3 were 48.9?months, 42.6?months, and 18.4?months, respectively. Protocol treatment was completed for all patients. Although most toxicities were Grade 1, genitourinary toxicity was common compared to gastrointestinal toxicity. Three-year biochemical control rate was 90.3%.
2019 | Year | 09 | Month | 17 | Day |
low and intermediate risk prostate cancer patients
Nine patients were enrolled in each level.
Although most toxicities were Grade 1, genitourinary toxicity was common compared to gastrointestinal toxicity.
Three-year biochemical control rate was 90.3%.
Completed
2011 | Year | 12 | Month | 21 | Day |
2011 | Year | 12 | Month | 21 | Day |
2012 | Year | 06 | Month | 06 | Day |
2015 | Year | 11 | Month | 03 | Day |
2015 | Year | 11 | Month | 03 | Day |
2013 | Year | 03 | Month | 13 | Day |
2019 | Year | 09 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011982
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