UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003629 |
|---|---|
| Receipt number | R000004401 |
| Scientific Title | Phase II study of surgical resection following neoadjuvant chemoradiation using Gemcitibine and TS-1 in patients with potentially and borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2018/11/23 20:44:10 |
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Basic information
Public title
Phase II study of surgical resection following neoadjuvant chemoradiation using Gemcitibine and TS-1 in patients with potentially and borderline resectable pancreatic cancer
Acronym
Phase II study of surgical resection following neoadjuvant chemoradiation in pancreatic cancer
Scientific Title
Phase II study of surgical resection following neoadjuvant chemoradiation using Gemcitibine and TS-1 in patients with potentially and borderline resectable pancreatic cancer
Scientific Title:Acronym
Phase II study of surgical resection following neoadjuvant chemoradiation in pancreatic cancer
Region
| Japan |
Condition
Condition
potentially and borderline resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to examine the efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of radical resection (R0)
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
| Medicine | Maneuver |
Interventions/Control_1
To investigate the frequency of histological curative resection following chemoradiation using Gemcitabine and TS-1in patients with potentially resectable pancreatic cancer
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.Patients with Histo-cytologically confirmed pancreatic cancer
2.Patients who have not undergone chemo and/or radiotherapy
3.Patients with radiologically defined patentially resectable pancreatic cancer
4.Patients with no metastatic disease confirmed by staging laparoscopy
5.Patients with Performance status of 0/1
6.Patients with sustained organ function
7.Patients with potentially resectable pancreatic cancer by CT following neoadjuvant chemoradiation
8.Patients who received informed consent
Key exclusion criteria
1) Patients with other active cancers
2) Patients with watery diarrhea
3) Intractable pleural and pericardical effusion, or ascites
4) Severe co-morbid diseases
5) Pregnancy or insufficient contraception
6) Past history of severe drug-allergy
7) Active bacterial or viral infection
8) younger than 20 years old or older than 90 years old.
9) No written informed consent of the patients
10) Pregnancy or insufficient contraception
11) HIV infection
12) Doubtful understanding or contractual capacity of the patient
13) Patients seems inadequate for this study by investigator(s)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI MD |
Organization
Kansai Medical University Hospital
Division name
Department of Surgery
Zip code
Address
2-3-1, Shin-machi, Hirakata, Osaka 573-1191
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI MD |
Organization
Kansai Medical University Hospita
Division name
Department of Surgery
Zip code
Address
TEL
Homepage URL
satoi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hospital
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
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
| 2010 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
| 2010 | Year | 05 | Month | 18 | Day |
Last modified on
| 2018 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004401
