UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030961 |
|---|---|
| Receipt number | R000035352 |
| Scientific Title | A phase 2 study of choledochojejunostomy in pagients with locally advanced pancreatic adenocarcinoma undergoing chemo-proton therapy. |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2018/01/23 23:46:36 |
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Basic information
Public title
A phase 2 study of choledochojejunostomy in pagients with locally advanced pancreatic adenocarcinoma undergoing chemo-proton therapy.
Acronym
Choledochojejunostomy for pancreatic adenocarcinoma undergoing chemo-proton therapy.
Scientific Title
A phase 2 study of choledochojejunostomy in pagients with locally advanced pancreatic adenocarcinoma undergoing chemo-proton therapy.
Scientific Title:Acronym
Choledochojejunostomy for pancreatic adenocarcinoma undergoing chemo-proton therapy.
Region
| Japan |
Condition
Condition
locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of choledochojejunostomy in patients with locally advanced pancreatic adenocarcinoma who are undergoing chemo-proton therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of unplanned delay or discontinuation of proton therapy
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Choledochojejunostomy before chemo-proton therapy
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 and Female
Key inclusion criteria
1. Locally advanced pancreatic cancer
2. Malignant bile duct ostruction
3. Pathologically confirmed adenocarcinoma / adenosquamous carcinoma
4. Age: >=20,80<
5. Aerformance Status (ECOG) 0/1
6. Sufficient function of important organs
7. Written informed consent
Key exclusion criteria
1. Past history of choledochojejunostomy
2. History of diseases which cause bile duct stenosis
3. Past history of abdominal irradiation
4. Inability of solid oral intake
5. Uncontrollable diabetes mellitus
6. Sever complication(heart failure, renal failure,liver failure,intestinal paralysis etc)
7. Acute coronary syndrome within 6 months, severe arrythmia
8. Consistent steroid use
9. Severe mental disorder
10. doctors decision not to be registered to this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirochika Toyama |
Organization
Kobe University
Division name
Division of Hepato-biliary-pancreatic Surgery Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6302
tymhr@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirochika Toyama |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-biliary-pancreatic Surgery Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6302
Homepage URL
tymhr@me.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Address
Tel
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
| 2018 | Year | 01 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2018 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035352
