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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002649
Receipt No. R000003226
Scientific Title Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer
Date of disclosure of the study information 2009/10/19
Last modified on 2018/04/26

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Basic information
Public title Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer
Acronym Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer
Scientific Title Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer
Scientific Title:Acronym Phase I/II study of preoperative chemoradiotherapy with Gemcitabine and S-1 for resectable pancreatic cancer
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 safety and feasibility, to determine recommended dose (RD) and to evaluate the efficacy of preoperative chemoradiotherapy with Gemcitabine and S-1 in patients with resectable pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase 1: Dose limiting toxicity, maximum tolerated dose, recommended dose
Phase 2: Pathological effect
Key secondary outcomes Response rate, Safety, Curative resection rate, Feasibility, Local recurrence rate, Relapse free survival (RFS), Overall survival (OS)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 preoperative chemoradiotherapy with Gemcitabine and S-1
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Histologically proven pancreatic adenocarcinoma
(2) Age between 20 and 80 years
(3) ECOG performance status of 0 or 1
(4) Surgically resectable
(5) Life Expectancy must be >=6 months
(6) Adequate hematologic, hepatic, renal and respiratory function
(7) Interval of at least 4 weeks between prior treatment and start of present study
(8) Written informed consent
Key exclusion criteria (1) Unresectable pancreatic cancer
(2) Presence or past history of Interstitial pneumonia or pulmonary fibrosis or possible
(3) Watery diarrhea
(4) Active infections (excluding viral hepatitis)
(5) Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus
(6) Presence of pleural effusion or ascites requiring drainage
(7) Presence of metastasis in central nervous system
(8) Active double cancer except carcinoma in situ or intramucosal cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 years)
(9) Treatment with phenytoin, potassium warfarin or flucytosine
(10) Pregnant females or nursing mothers who can not stop lactation. Patients or partners, who don't attempt to doing contraception during the study period.
(11) Severe mental disorder
(12) Severe drug hypersensitivity
(13) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Eguchi
Organization Osaka University
Division name Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Email heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidetoshi Eguchi
Organization Osaka University
Division name Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Homepage URL
Email heguchi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka
Institute
Department

Funding Source
Organization None (Self-funding)
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
Email

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
2009 Year 10 Month 19 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 No longer recruiting
Date of protocol fixation
2009 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2020 Year 08 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
2009 Year 10 Month 19 Day
Last modified on
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003226

Research Plan
Registered date File name
2014/12/24 CSGO-HBP-003_切除可能GSRT_プロトコル.docx

Research case data specifications
Registered date File name
2014/12/24 CSGO-HBP-003_切除可能GSRT_CRF.doc

Research case data
Registered date File name


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