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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010236
Receipt No. 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

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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
Email 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
Email hishiyam@kitasato-u.ac.jp

Sponsor
Institute Kitasato univeristy school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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