UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037680 |
|---|---|
| Receipt number | R000042971 |
| Scientific Title | A prospective QOL survey of carbon ion radiotherapy in 12 fractions for prostate cancer |
| Date of disclosure of the study information | 2019/08/14 |
| Last modified on | 2024/08/17 17:07:08 |
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Basic information
Public title
A prospective QOL survey of carbon ion radiotherapy in 12 fractions for prostate cancer
Acronym
A prospective QOL survey of carbon ion radiotherapy in 12 fractions for prostate cancer
Scientific Title
A prospective QOL survey of carbon ion radiotherapy in 12 fractions for prostate cancer
Scientific Title:Acronym
A prospective QOL survey of carbon ion radiotherapy in 12 fractions for prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the quality of life of carbon ion radiotherapyin 12 fractions for prostate cancer.
Basic objectives2
Others
Basic objectives -Others
QOL survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expanded Prostate Cancer Index Composite (EPIC)
Short Form with 8 questions (SF-8)
EuroQol 5 Dimension (EQ-5D(5L))
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Prostate cancer (adenocarcinoma) that has been confirmed by biopsy.
2) T1c-T3N0M0 (2009, UICC 7th edition).
3) The age at the time of registration is 20 to 80 years old.
4) Performance Status (ECOG) is 0-2.
5) The name and condition of the disease have been announced to the person.
6) The person must be able to agree.
Key exclusion criteria
1) History of radiation therapy in the pelvis.
2) Active double cancer (simultaneous double cancer and metachronous double cancer with a disease-free period of 5 years or less). However, lesions equivalent to intraepithelial cancer or intramucosal cancer that are judged to be cured by local treatment are not included in active double cancer.
3) Patients who have undergone prior endocrine therapy and deviate from the endocrine therapy combination rule according to the risk.
4) castration resistant at the time of enrollment.
5) Patients who refuse to use endocrine therapy according to risk.
6) Cases with serious complications
7) Medical doctors determine that the doctor in charge is inappropriate due to medical, psychological or other factors.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Kawamura |
Organization
Gunma University Hospital
Division name
Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showamachi, Maebashi
TEL
027-220-8378
kawa@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Kawamura |
Organization
Gunma University Hospital
Division name
Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showamachi, Maebashi
TEL
027-220-8378
Homepage URL
kawa@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-22 Showamachi, Maebashi
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.ac.jp
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
| 2019 | Year | 08 | Month | 14 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will use the Expanded Prostate Cancer Index Composite (EPIC) as a QOL assessment specific to prostate cancer and the Short Form with 8 questions (SF-8) as a comprehensive QOL assessment standard. In addition, the survey will be conducted using the EuroQol 5 Dimension (EQ-5D (5L)) questionnaire, which can calculate the quality-adjusted survival year as a short-term and long-term evaluation standard.
Management information
Registered date
| 2019 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042971
