UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053762 |
|---|---|
| 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 |
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Basic information
Public title
Prospective Clinical Trial of Moderately Hypo-fractionated Intensity Modulated Radiation Therapy with Concurrent Administration of Daikenchuto for Prostate Cancer
Acronym
DKTR PRO Trial
Scientific Title
Prospective Clinical Trial of Moderately Hypo-fractionated Intensity Modulated Radiation Therapy with Concurrent Administration of Daikenchuto for Prostate Cancer
Scientific Title:Acronym
DKTR PRO Trial
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We prospectively investigate the efficacy of moderately hypo-fractionated IMRT with concurrently administration of daikenchuto for patients with prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
3-year rate of radiotherapy-related late gastrointestinal adverse events : rate of rectal bleeding due to radiation proctitis
Key secondary outcomes
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.
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
| Medicine |
Interventions/Control_1
Moderately hypo-fractionated intensity modulated radiation therapy (63Gy in 21 fractions) with concurrently administration of daikenchuto
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Masateru |
| Middle name | |
| Last name | Fujiwara |
Organization
Suita Tokushukai Hospital
Division name
Depaertment of Radiation Oncology
Zip code
565-0814
Address
21-1, Senriokanishi, Suita-city, Osaka
TEL
0668781110
fujiwara.hasumi@gmail.com
Public contact
Name of contact person
| 1st name | Masateru |
| Middle name | |
| Last name | Fujiwara |
Organization
Suita Tokushukai Hospital
Division name
Depaertment of Radiation Oncology
Zip code
565-0814
Address
21-1, Senriokanishi, Suita-city, Osaka
TEL
0668781110
Homepage URL
fujiwara.hasumi@gmail.com
Sponsor or person
Institute
Suita Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
| 2024 | Year | 04 | Month | 23 | Day |
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061352
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| Registered date | File name |
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