UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049855 |
|---|---|
| Receipt number | R000056322 |
| Scientific Title | Multicenter phase II clinical trial of preoperative chemotherapy and hyperbaric oxygen therapy for resectable pancreatic cancer |
| Date of disclosure of the study information | 2023/01/04 |
| Last modified on | 2023/01/27 14:57:59 |
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Basic information
Public title
Safety and efficacy of preoperative combination therapy of chemotherapy and hyperbaric oxygen therapy for resectable pancreatic cancer
Acronym
Effect of chemotherapy and hyperbaric oxygen therapy in preoperative therapy for pancreatic cancer
Scientific Title
Multicenter phase II clinical trial of preoperative chemotherapy and hyperbaric oxygen therapy for resectable pancreatic cancer
Scientific Title:Acronym
Preoperative therapy (chemotherapy and hyperbaric oxygen therapy) for resectable pancreatic cancer
Region
| Japan |
Condition
Condition
Resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and feasibility for chemotherapy and hyperbaric oxygen therapy as neoadjuvant therapy against resectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 year relapse-free survival
Key secondary outcomes
Adverse effect
Dose intensity
Resectability rate
Pathological effect
Tumor marker
Tumor volume
Form of recurrence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Treatment with chemotherapy and hyperbaric oxygen therapy;
Chemotherapy: 2 courses
S-1 40 mg/m2 twice a day for 14 days followed by a 7 days rest +
Gemcitabine 1,000mg/m2 on days 1 and day 8 every 3 weeks
Hyperbaric oxygen therapy :
A total of 4 times on the same schedule as gemcitabine administration.
2 atmospheres for 60 minutes/time
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) invasive ductal carcinoma of the pancreas
2) resectable pancreatic cancer at diagnosis
3) no distant metastasis
4) R0/1 resectable
5) Negative cytology of washed ascites by staging laparotomy
6) all adult who anticipate to undergo pancreatectomy
7) no prior therapy
8) written informed consent
Key exclusion criteria
1) pulmonary fibrosis or interstitial pneumonitis
2) frequent watery diarrhea that is resistant to treatment
3) active double cancer
4) distant metastasis
5) R2 resection
6) prior anti-cnacer therapy
7) pregnancy
8) a history of spontaneous pneumothorax, bronchial asthma, open-heart surgery, etc., and who are at risk of acute ventilation failure
9) ophthalmic treatment/after surgery (when intraocular pressure gas C3F8, SF6 is used for retinal detachment, etc.)
10) Difficult to tolerate radical surgery
11) Have an active infectious disease (fever 38.0 degrees or higher)
12) those who do not have sufficient judgment to obtain consent for this research
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Mekata |
Organization
National Hospital Organization Higashi-Ohmi General Medical Center
Division name
Division of Surgery
Zip code
527-8505
Address
255, Gochi-cho, Higashioumi, Shiga, Japan
TEL
0748-22-3030
mekata@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Akabori |
Organization
National Hospital Organization Higashi-Ohmi General Medical Center
Division name
Division of Surgery
Zip code
527-8505
Address
255, Gochi-cho, Higashiohmi City, Shiga, Japan
TEL
0748-22-3030
Homepage URL
hakabori@belle.shiga-med.ac.jp
Sponsor or person
Institute
Division of Surgery
National Hospital Organization Higashi-Ohmi General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Review Board, National Hospital Organization Higashi-Ohmi General Medical Center
Address
255, Gochi-cho, Higashiohmi City, Shiga, Japan
Tel
0748223030
402-higashiomishomu@mail.hosp.go.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
淡海医療センター(滋賀県) Omi Medical Center
日野記念病院(滋賀県) Hino Memorial Hospital
東近江総合医療センター(滋賀県) National Hospital Organization Higashi-Ohmi General Medical Center
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 04 | 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 | 11 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056322
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