UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046456 |
|---|---|
| Receipt number | R000053010 |
| Scientific Title | Clinical efficacy study of neoadjuvant therapy with intensity-modulated radiotherapy combined with S-1 for resectable pancreatic cancer |
| Date of disclosure of the study information | 2021/12/25 |
| Last modified on | 2024/07/07 11:13:38 |
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Basic information
Public title
Clinical efficacy study of neoadjuvant therapy with intensity-modulated radiotherapy combined with S-1 for resectable pancreatic cancer
Acronym
NAC-IMRT for resectable pancreatic cancer
Scientific Title
Clinical efficacy study of neoadjuvant therapy with intensity-modulated radiotherapy combined with S-1 for resectable pancreatic cancer
Scientific Title:Acronym
NAC-IMRT for resectable pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validity verification of neoadjuvant therapy with intensity-modulated radiotherapy combined with S-1 for resectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival for 2 years
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
intensity-modulated radiotherapy combined with S-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.Patients with resectable pancreatic
2.Pathological diagnosis
3.Biliary drainage for obstructive jaundice
4.Given consent for this clinical trial
Key exclusion criteria
1.Performance status: 2-4 (according to ECOG criteria)
2.Difficulty in oral intake
3.Severe hepatic or renal impairment
4.Active infectious disease
5.History of radiation therapy for abdominal organs
6.In case the attending physician deems it inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | okamura |
Organization
kyoto Katsura Hospital
Division name
Surgery
Zip code
615-8256
Address
17 Yamadahirao-cho, Nishikyo-ku, Kyoto City, Kyoto
TEL
075-391-5811
yusuke531979@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Okamura |
Organization
Kyoto Katsura Hospital
Division name
Surgery
Zip code
615-8256
Address
17 Yamadahirao-cho, Nishikyo-ku, Kyoto City, Kyoto
TEL
075-391-5811
Homepage URL
yusuke531979@yahoo.co.jp
Sponsor or person
Institute
Kyoto Katsura Hospital
Institute
Department
Personal name
Funding Source
Organization
not appicapable
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
kyoto Katsura Hospital
Address
17 Yamadahirao-cho, Nishikyo-ku, Kyoto City, Kyoto
Tel
0753915811
yusuke531979@yahoo.co.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
| 2021 | Year | 12 | Month | 25 | 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
| Delay expected |
Results Delay Reason
Delayed enrollment
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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 23 | Day |
Last modified on
| 2024 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053010
