Unique ID issued by UMIN | UMIN000007810 |
---|---|
Receipt number | R000009201 |
Scientific Title | Phase II study of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer |
Date of disclosure of the study information | 2012/07/02 |
Last modified on | 2017/04/26 22:14:40 |
Phase II study of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer
Phase II study of hypofractionated radiation therapy for prostate cancer
Phase II study of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer
Phase II study of hypofractionated radiation therapy for prostate cancer
Japan |
prostate cancer
Urology | Radiology | Adult |
Malignancy
NO
To evaluate the safety and efficacy of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Incidence of late morbidity
Incidence of acute morbidity, biochemical failure free survival, clinical progression free survival, overall Survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Intensity-modulated radiation therapy with 70 Gy delivered at 2.5-Gy/fraction using image-guided radiation techniques
50 | years-old | <= |
80 | years-old | > |
Male
1) Histologically proved prostate cancer(adenocarcinoma)
2) Low or intermediate risk prostate cancer(T1-T2c and PSA =<20 and G =<7) or high risk cancer with one of high risk factors (T3a, 20< PSA =<30 or G=8,9)
3) 50y.o. <= age < 80 y.o.
4) ECOG performance status 0-1
5))Written informed consent
1) Cancer patients with a duplication of activity
2) Patients with severe or uncontrollable diabetes
3) Serious medical complications (uncontrollable pulmonary disease, heart disease, kidney disease, liver disease)
4) Mental diseases which prevent from registration of this trial
5) History of pelvic radiation therapy
6) History of abdominal or pelvic surgery
7) History of prostate surgery including HIFU
8) History of chemotherapy for prostate cancer
9) Patients with inflammatory bowel disease
10) Patients treated with anticoagulant
11) IPSS >= 20
12) Risk organs are too close to the PTV to keep dose constraints.
13) Patients with metal artifacts in pelvic CT images.
130
1st name | |
Middle name | |
Last name | Yoshikazu Kagami |
Showa University School of Medicine
Department of Radiology
Hatanodai 1-5-8, Tokyo, Japan
03-6426-3228
kagami@med.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Katsumasa Nakamura |
Kyushu University Hospital
Department of Radiology
Maidashi 3-1-1, Fukuoka, Japan
092-642-5695
http://plaza.umin.ac.jp/~hypo_rt/
nakam@radiol.med.kyushu-u.ac.jp
Ministry of Health, Labour and Welfare scientific research Kagami squad
Ministry of Health, Labour and Welfare
Japanese Governmental office
NO
2012 | Year | 07 | Month | 02 | Day |
http://hypo_rt.umin.jp/index.html
Unpublished
No longer recruiting
2012 | Year | 04 | Month | 20 | Day |
2012 | Year | 07 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
2012 | Year | 04 | Month | 22 | Day |
2017 | Year | 04 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009201
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |