UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029312 |
|---|---|
| Receipt number | R000033433 |
| Scientific Title | Local Radiation for T4 Disease of Metastatic Prostate Cancer |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2017/09/27 17:15:44 |
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Basic information
Public title
Local Radiation for T4 Disease of Metastatic Prostate Cancer
Acronym
LOR-TIP
Scientific Title
Local Radiation for T4 Disease of Metastatic Prostate Cancer
Scientific Title:Acronym
LOR-TIP
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the purpose of this study is to evaluate the efficacy and safety of local radiation thrapy for metastatic prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
local progression-related events free survival
Key secondary outcomes
1)PSA response rate
2)PSA-progression-free survival
3)Overall survival
4)Progression-free survival
5)Time to Treatment for local events
6)QOL assessment (SF12, FACT-P)
7)CTCAE ver4.0
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
primary androgen deprivation therapy+
Intensity Modulated Radiation Therapy(IMRT) 70~78Gy
Interventions/Control_2
primary androgen deprivation therapy
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Pathologically confirmed prostate cancer with T4 2. No previous cytotoxic intravenous systemic chemotherapy
2. No evidence of clinical progression with 6 months primary androgen depriation therapy
3. >=40 years old
4. able to take oral medications
5. Life expectancy >6 months
6. ECOG PS 0-3
7.a-g WBC>=3000/mm3, Hb>=9g/dl, Plt>=75000/mm3, Serum creatinine <=3.0mg/dl, Total bilirubin <=1.8mg/dl, aspartate aminotransferase <=90 IU/l, alanine aminotransferase<=100 IU/l,
8. Obtained infromed consent with document
Key exclusion criteria
1.No previous radiation therapy for prostate cancer
2.Allergy for androgen deprivation therapy
3. Patients who were judged unfit for enrollment by physicians in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Masumori |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
Address
S1, W16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
masumori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Hashimoto |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
Address
S1, W16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
Homepage URL
hashimoto.kouhei@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
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
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
| 2018 | Year | 04 | Month | 01 | 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
| 2017 | Year | 02 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 27 | Day |
Last modified on
| 2017 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033433
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
