UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009634
Receipt No. 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

* 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/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
Email 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
Email fmotoi@surg.med.tohoku.ac.jp

Sponsor
Institute Study group of preoperative therapy for pancreatic cancer (PREP)/Japanese Study Group of Adjuvant Therapy for pancreatic Cancer (JSAP)
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010813

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.