UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049456 |
|---|---|
| Receipt number | R000055475 |
| Scientific Title | Prospective cohort study to evaluate feasibility and efficacy of systemic chemotherapy followed by carbon-ion radiotherapy for unresectable locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2022/11/08 |
| Last modified on | 2022/11/08 11:18:47 |
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Basic information
Public title
Prospective cohort study to evaluate feasibility and efficacy of systemic chemotherapy followed by carbon-ion radiotherapy for unresectable locally advanced pancreatic cancer
Acronym
Yu-PANC-01
Scientific Title
Prospective cohort study to evaluate feasibility and efficacy of systemic chemotherapy followed by carbon-ion radiotherapy for unresectable locally advanced pancreatic cancer
Scientific Title:Acronym
Yu-PANC-01
Region
| Japan |
Condition
Condition
Unresectable locally-advanced 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 feasibility and efficacy of systemic chemotherapy followed by carbon-ion radiotherapy for unresectable locally-advanced pancreatic cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease control rate for 6 months with systemic chemotherapy followed by carbon-ion radiotherapy
Key secondary outcomes
Response rate, Tumor reduction rate, Tumor marker kinetics during the therapy, Overall survival, Progression-free survival, Adverse events, Dose intensity of the agents.
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
| 18 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histological or cytological confirmation of malignancy.
2. Radiologically diagnosed as pancreatic ductal adenocarcinoma.
3. Unresectable locally-advanced (UR-LA) or Borderline resectable with arterial abutment (BR-A), confirmed by CT-imaging.
4. No obvious distant metastatic findings.
5. Age of over 17 and under 80.
6. Performance status is 0 or 1 (ECOG).
7. Measurable disease.
8. Chemotherapy or Radiotherapy naive for pancreatic cancer.
9. Able to eat orally.
10. No serious comorbidity.
11. No active and ongoing other malignancy.
12. No pregnancy, planing pregnancy or baby.
13. No peripheral neuropathy.
14. Written informed consent.
Key exclusion criteria
1. No histological or cytological confirmation of malignancy.
2. Resectable (R) or Borderline resectable without arterial abutment (BR-PV).
3. Radiological distant metastases.
4. Age of under 18 or over 79.
5. Performance status is 2 or 3 (ECOG).
6. No measurable disease.
7. Previous treatment with chemotherapy or radiotherapy for pancreatic cancer.
8. Unable to eat orally.
9. Serious comorbidity.
10. Active and ongoing other malignancy.
11. Pregnancy, planing pregnancy or baby.
12. Peripheral neuropathy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Motoi |
| Middle name | |
| Last name | Fuyuhiko |
Organization
Yamagata University
Division name
Department of Surgery I
Zip code
990-9585
Address
2-2-2, Iida-Nishi, Yamagata
TEL
023-628-5334
fmotoi@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoi |
| Middle name | |
| Last name | Fuyuhiko |
Organization
Yamagata University
Division name
Department of Surgery I
Zip code
990-9585
Address
2-2-2, Iida-Nishi, Yamagata
TEL
023-628-5334
Homepage URL
http://www.surgery1-yamagata.net/index.html
fmotoi@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Yamagata University
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
The ethic review committee of facluty of medicine, Yamagata University
Address
2-2-2, Iida-Nishi, Yamagata
Tel
023-633-1122
yu-ikekenkyu@jm.kj.yamagata-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
| 2022 | Year | 11 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Definition of "Disease Control" (after more than 6 months.)
1) CR or PR or SD (without any new lesion) by RECIST criteria.
2) Tumor marker decrease after treatment.
Management information
Registered date
| 2022 | Year | 11 | Month | 08 | Day |
Last modified on
| 2022 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055475
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| Registered date | File name |
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| Registered date | File name |
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