UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005912 |
|---|---|
| Receipt number | R000006991 |
| Scientific Title | Phase II study of neo-adjuvant chemotherapy with combination therapy of gemcitabine and S-1 in patients with resectable pancreatic cancer |
| Date of disclosure of the study information | 2011/07/03 |
| Last modified on | 2012/07/30 13:28:53 |
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Basic information
Public title
Phase II study of neo-adjuvant chemotherapy with combination therapy of gemcitabine and S-1 in patients with resectable pancreatic cancer
Acronym
PK-NACGS PhaseII
Scientific Title
Phase II study of neo-adjuvant chemotherapy with combination therapy of gemcitabine and S-1 in patients with resectable pancreatic cancer
Scientific Title:Acronym
PK-NACGS PhaseII
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 feasibilty for gemcitabine and S-1 therapy as neoadjuvant against resectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
resection rate, adverse effect, completion rate, recurrence free survival, two-year survival rate, pathological effect
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
Gemcitabine(1000mg/m2) is given by intravenous infusion over 30 min on day1, 8. S-1(65mg/m2) is given oral for 14 days followed by a 1-week rest. This cycle was repeated twice.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)resectable or borderline resectable pancreatic cancer
2)sytologically or histrogically proven pancreatic invasive ductal cancer
3)all adult who anticipate to undergo pancreatectomy
4)Eastern Cooperative Oncology Group performance status of 0-1
5)adequate oral intake
6)adequate organ function
7)written informed consent
Key exclusion criteria
1)pulmonary fibrosis or interstitional pneumonaitis
2)prior anti-cancer therapy(chemotherapy,radiation therapy ,chemoradiation therapy)
3)active infection
4)syncronous cancers
5)severe complication
6)severe mental disorder
7)watery diarrhea
8)pregnancy
9)iodine allergy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Nakagori |
Organization
Tokai university, school of medicine
Division name
Gastroenterological surgery
Zip code
Address
143 simokasuya, isehara, kanagawa, Japan
TEL
0463-93-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokai university, school of medicine
Division name
Gastroenterological surgery
Zip code
Address
TEL
Homepage URL
furufuru@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai university, school of medicine
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
Tokai University Hachioji Hospital
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
| 2011 | Year | 07 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
| 2011 | Year | 07 | Month | 03 | Day |
Last modified on
| 2012 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006991
