UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009634 |
|---|---|
| Receipt number | R000010813 |
| Scientific Title | Phase II/III study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemotherapy for resectable pancreatic cancer (Prep-02/JSAP-05) |
| Date of disclosure of the study information | 2012/12/26 |
| Last modified on | 2019/07/04 09:22:36 |
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Basic information
Public title
Phase II/III study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemotherapy for resectable pancreatic cancer (Prep-02/JSAP-05)
Acronym
Neoadjuvant GS therapy for pancreatic cancer : Prep-02/JSAP-05
Scientific Title
Phase II/III study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemotherapy for resectable pancreatic cancer (Prep-02/JSAP-05)
Scientific Title:Acronym
Neoadjuvant GS therapy for pancreatic cancer : Prep-02/JSAP-05
Region
| Japan |
Condition
Condition
Resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase II: To evaluate the equivalence of safety and resection rate for neoadjuvant GS therapy comparing standard therapy.
Phase III: To evaluate superiority in survival of neoadjuvant GS therapy against standard surgery-first therapy in patients with resectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Phase II: Resection rate
Phase III: Overall survival
Key secondary outcomes
Phase II: Adverse events
Phase III: Adverse events, Resection rate, Residual tumor, Nodal involvement rate, Histological response, Relapse-free survival, Tumor marker kinetics, Dose intensity, Patterns of Recurrence, Radiological tumor response
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Neoadjuvant chemotherapy with gemcitabine and S-1 followed by surgery and adjuvant with 4 course of oral S-1 (Test arm).
Interventions/Control_2
Surgery and adjuvant with 4 course of oral S-1 (Control arm).
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) invasive ductal carcinoma of the pancreas
2) no distant metastasis
3) R0/1 resectable
4) all adult who anticipate to undergo pancreatectomy
5) no prior therapy
6) written informed consent
6) ECOG performance status of 0 or 1
7) Adequate organ function
8) Written informed consent
Key exclusion criteria
1) pulmonary fibrosis or interstitial pneumonitis
2) Uncontrolled watery diarrhea
3) Active double cancer
4) Active infection
5) HBs antigen positive
6) Pregnant females, possibly pregnant females
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Unno |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of gastroenterological surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
m_unno@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Fuyuhiko |
| Middle name | |
| Last name | Motoi |
Organization
Tohoku University Graduate School of Medicine
Division name
Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
http://www.surg.med.tohoku.ac.jp/society/prep02.html
fmotoi@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Study group of preoperative therapy for pancreatic cancer (PREP)/Japanese Study Group of Adjuvant Therapy for pancreatic Cancer (JSAP)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Tohoku Univ.
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
Tel
022-717-8007
rinri-2@proj.med.tohoku.ac.jp
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
| 2012 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://meetinglibrary.asco.org/record/169433/abstract
Number of participants that the trial has enrolled
364
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
Main results already published
Date of protocol fixation
| 2012 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010813
