UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010236 |
|---|---|
| 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 |
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Basic information
Public title
Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Acronym
Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Scientific Title
Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Scientific Title:Acronym
Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Region
| Japan |
Condition
Condition
low risk prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the maximum tolerated dose (MTD) and recommended dose (RD) for one fraction of hypofractionated intensity modulated radiotherapy with 4 fractions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
maximum tolerated dose and recommended dose
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Radiotherapy
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
*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
Key exclusion criteria
*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
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazushige Hayakawa |
Organization
Kitasato university school of medicine
Division name
Radiology and Radiation Oncology
Zip code
Address
1-15-1 Kitasato, Sagamiharashiminamiku, Kanagawa, Japan
TEL
042-778-8453
hayakazu@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Ishiyama |
Organization
Kitasatoo university school of medicine
Division name
Radiology and Radiation Oncology
Zip code
Address
1-15-1 Kitasato, Sagamiharashi-minamiku, kanagawa Japan
TEL
042-778-8453
Homepage URL
hishiyam@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato univeristy school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/31477122
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/31477122
Number of participants that the trial has enrolled
27
Results
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%.
Results date posted
| 2019 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
low and intermediate risk prostate cancer patients
Participant flow
Nine patients were enrolled in each level.
Adverse events
Although most toxicities were Grade 1, genitourinary toxicity was common compared to gastrointestinal toxicity.
Outcome measures
Three-year biochemical control rate was 90.3%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 11 | Month | 03 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 13 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011982
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