Unique ID issued by UMIN | UMIN000053762 |
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Receipt number | R000061352 |
Scientific Title | Prospective Clinical Trial of Moderately Hypo-fractionated Intensity Modulated Radiation Therapy with Concurrent Administration of Daikenchuto for Prostate Cancer |
Date of disclosure of the study information | 2024/04/23 |
Last modified on | 2024/05/02 07:49:30 |
Prospective Clinical Trial of Moderately Hypo-fractionated Intensity Modulated Radiation Therapy with Concurrent Administration of Daikenchuto for Prostate Cancer
DKTR PRO Trial
Prospective Clinical Trial of Moderately Hypo-fractionated Intensity Modulated Radiation Therapy with Concurrent Administration of Daikenchuto for Prostate Cancer
DKTR PRO Trial
Japan |
Prostate cancer
Radiology |
Malignancy
NO
We prospectively investigate the efficacy of moderately hypo-fractionated IMRT with concurrently administration of daikenchuto for patients with prostate cancer.
Safety,Efficacy
Confirmatory
Pragmatic
3-year rate of radiotherapy-related late gastrointestinal adverse events : rate of rectal bleeding due to radiation proctitis
3-year and 5-year rate of radiotherapy-related late adverse events, 3-year and 5-year biological recurrence-free rate, 3-year and 5-year overall survival rate, patient-reported outcomes, and QOL evaluation using the IPSS and EPIC.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Moderately hypo-fractionated intensity modulated radiation therapy (63Gy in 21 fractions) with concurrently administration of daikenchuto
20 | years-old | <= |
Not applicable |
Male
1) Patients eligible for radical intensity modulated radiation therapy (localized irradiation to the prostate + seminal vesicles) for prostate cancer
2) Male patients aged 20 years or older at the time of informed consent
3) Patients with an ECOG PS score of 2 or less who are able to visit the outpatient clinic
4) Research subjects who have given their own free written consent after receiving sufficient explanation to participate in this research
1)Patients with a history of active multiple cancers
2) Patients who are suitable for radical intensity-modulated radiotherapy for prostate cancer, but who are judged to require combination therapy with pelvic irradiation due to pelvic lymph node metastases
3)Patients who have undergone pelvic surgery or radiation therapy before obtaining consent
4)Patients who have been taking regular Chinese herbal medicines including Daikenchuto since before consent was obtained
5) Patients who are already known to be allergic to Daikenchuto and the herbal medicines contained in this drug
6) Patients who are unable to collect urine during radiotherapy due to co-morbidities such as hemodialysis
7) Patients with a history of transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia as a comorbidity
8) Patients who are self-catheterized or have a urinary catheter continuously in place due to urinary retention or severe urinary difficulty as a comorbidity
9) Patients with a history of inflammatory bowel disease such as ulcerative colitis or Crohn's disease as a comorbidity
10)Patients with persistent lower gastrointestinal bleeding symptoms due to hemorrhoids etc. as a comorbidity
11)Patients with interstitial pneumonia as a comorbidity
12)Patients with collagen disease as a comorbidity
13) Patients with serious liver disease (AST (GOT) or ALT (GPT) 100 U or more)
14) Patients with severe renal disease (creatinine 2.0 mg/dl or more)
15)Other patients deemed unsuitable as research subjects by the research director
125
1st name | Masateru |
Middle name | |
Last name | Fujiwara |
Suita Tokushukai Hospital
Depaertment of Radiation Oncology
565-0814
21-1, Senriokanishi, Suita-city, Osaka
0668781110
fujiwara.hasumi@gmail.com
1st name | Masateru |
Middle name | |
Last name | Fujiwara |
Suita Tokushukai Hospital
Depaertment of Radiation Oncology
565-0814
21-1, Senriokanishi, Suita-city, Osaka
0668781110
fujiwara.hasumi@gmail.com
Suita Tokushukai Hospital
None
Self funding
The Tokushukai Group Ethics Committee
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
03-3263-4801
mirai-ec1@mirai-iryo.com
NO
2024 | Year | 04 | Month | 23 | Day |
Unpublished
Open public recruiting
2024 | Year | 02 | Month | 14 | Day |
2024 | Year | 04 | Month | 16 | Day |
2024 | Year | 04 | Month | 17 | Day |
2032 | Year | 03 | Month | 31 | Day |
2024 | Year | 03 | Month | 03 | Day |
2024 | Year | 05 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061352
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