UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001450 |
|---|---|
| Receipt number | R000001672 |
| Scientific Title | Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2008/10/21 |
| Last modified on | 2016/05/13 15:25:35 |
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Basic information
Public title
Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Acronym
Phase II trial of neoadjuvant chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Scientific Title
Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Scientific Title:Acronym
Phase II trial of neoadjuvant chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to assess the pathologically margin negative status after GS therapy in patients with locally advanced, unresectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
pathologically margin negative status
Key secondary outcomes
response rate, toxicity, progression free survival, overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S1: bid d1-15 q3w x 3 courses 60mg/sq PO
GEM: d1 and d1, q3w x 3 courses 1000mg/sq DIV
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)Histologically proven pancreatic adenocarcinoma
2)UICC stageIII with one of the criteria below; a)tumor abutment of the SMA involving half of the artery circumference b)encasement of a short segment of HA without tumor extension to the celiac axis
3)No prior chemotherapy or radiotherapy
4)Age above 20
5)ECOG performance status of 0 or 1
6)Adequate hematologic, hepatic and renal function
7)Written informed consent
Key exclusion criteria
1)Watery diarrhea
2)Severe mental disorder
3)Active infection
4)Severe complications, such as ileus, heart failure and renal failure
5)Symptomatic pulmonary fibrosis or interstitial pneumonia
6)History of radiation therapy to the chest
7)Marked pleural or peritoneal effusion
8)Active concomitant malignancy
9)Treatment with phenytoin, potassium warfarin or flucytosine
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiya Kawaguchi |
Organization
Faculty of Medicine, Kyoto University
Division name
Surgery
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University
Division name
Surgery
Zip code
Address
TEL
Homepage URL
tmasui@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kyoto University
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
| 2008 | Year | 10 | Month | 21 | 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
| 2008 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 21 | Day |
Last modified on
| 2016 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001672
