UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045916 |
|---|---|
| Receipt number | R000052405 |
| Scientific Title | Prospective observational study of stereotactic body radiation therapy for pancreatic cancer |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2023/11/01 18:21:55 |
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Basic information
Public title
Prospective observational study of stereotactic body radiation therapy for pancreatic cancer
Acronym
Prospective observational study of stereotactic body radiation therapy for pancreatic cancer
Scientific Title
Prospective observational study of stereotactic body radiation therapy for pancreatic cancer
Scientific Title:Acronym
Prospective observational study of stereotactic body radiation therapy for pancreatic cancer
Region
| Japan |
Condition
Condition
localized pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of stereotactic body radiotherapy for localized pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Overall survival
Key secondary outcomes
2. Toxicity
3. Progression free survival
4. Local control
5. Quality of life
6. Actual status of radiation therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. ECOG performance status of 0-2
2. Patients with pathologically proven or clinically diagnosed pancreatic cancer
3. Stereotactic radiation therapy for pancreatic cancer is planned
4. Written informed consent
Key exclusion criteria
1. History of previous radiation therapy or surgery for pancreatic cancer.
2. Patients who are pregnant or suspected to be pregnant.
3. Patients who are breastfeeding.
4. Patients with severe psychological disorder
5. Inappropriate for study participation by the lead principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Katoh |
Organization
Hokkaido University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5977
noriwokatoh@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Katoh |
Organization
Hokkaido University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5977
Homepage URL
noriwokatoh@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Faculty 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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 29 | 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
| 2021 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Target number of registrations: 30 cases
Registration: Sep 2021 to Mar 2025
Follow up: Until Mar 2027
Management information
Registered date
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052405
