UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003088 |
|---|---|
| Receipt number | R000003750 |
| Scientific Title | Phase II study of pre-operative chemoradiation using S-1 followed by surgical resection for potentially resectable and locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2010/01/26 |
| Last modified on | 2019/04/01 18:20:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of pre-operative chemoradiation using S-1 followed by surgical resection for potentially resectable and locally advanced pancreatic cancer
Acronym
Phase II study of pre-operative chemoradiation for pancreatic cancer
Scientific Title
Phase II study of pre-operative chemoradiation using S-1 followed by surgical resection for potentially resectable and locally advanced pancreatic cancer
Scientific Title:Acronym
Phase II study of pre-operative chemoradiation for pancreatic cancer
Region
| Japan |
Condition
Condition
Potentially resectable and locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and clinical effect of pre-operative chemoradiation followed by surgical resection in patients with potentially resectable and locally advanced pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Frequency of histological curative resection or surgical curative resection
Key secondary outcomes
Response rate of chemoradiation therapy
Grading of histological response of chemoradiation therapy
Safety of chemoradiation followed by surgical resection
Operative mortality and morbidity
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 |
Interventions/Control_1
To investigate the frequency of histological (surgical) curative resection following chemoradiation using S-1in patients with potentially resectable and locally advanced 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Histo-cytologically confirmed pancreatic cancer radiographically defined as potentially resectable and locally advanced
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 M.D. |
Organization
Kansai Medical University, Hirakata hospital
Division name
Department of surgery
Zip code
Address
2-3-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI M.D. |
Organization
Kansai Medical University, Hirakata hospital
Division name
Department of surgery
Zip code
Address
2-3-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Department of Surgery, Kansai Medical University Hirakataka 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 | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2007 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 25 | Day |
Last modified on
| 2019 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003750
