UMIN-CTR Clinical Trial

Basic information
Public title	A phase 2 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer
Acronym	GSL-2
Scientific Title	A phase 2 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer
Scientific Title:Acronym	GSL-2
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of GEM+S-1+LV combination therapy for pancreatic cancers
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Overall survival, response rate, disease control rate, adverse events

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	GEM+S-1+LV combination therapy GEM:1,000mg/m2, day1 S-1:80mg/day(BSA<1.25/m2) 100mg/day(1.25/m2=<BSA<1.5/m2) 120mg/day(BSA=>1.5/m2), day1-7 LV:50mg/day, day1-7 repeated every 2weeks.
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) Patients with unresectable pancreatic cancer without prior treatment 2) Patients with pathologically proven pancreatic cancer 3) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 4) Patients of age >= 20 years 5) Patients who can eat 6) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, neutophils >=1,500/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal 7) Estimated survival > 2months 8) Written informed consent is required from all patients.
Key exclusion criteria	1) Patients with systolic blood pressure < 100mmHg 2) Patients with an active concomitant infection 3) Patients with digestive ulcer or gastrointestinal bleeding, severe heart or renal disease 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with severe diarrhea 6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 7) Patients with uncontrollable massive pleural effusion or massive ascites 8) Patients with an active concomitant malignancy 9) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size	49

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroyuki Isayama
Organization	The University of Tokyo
Division name	Gastroenterology
Zip code
Address	7-3-1, Hongo Bunkyo-ku Tokyo
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name Kei Saito
Organization	The University of Tokyo Hospital
Division name	Department of Gastroenterology
Zip code
Address	7-3-1, Hongo Bunkyo-ku Tokyo
TEL	03-3815-5411
Homepage URL
Email

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

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
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	東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 15 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	Completed
Date of protocol fixation	2013 Year 04 Month 30 Day
Date of IRB	2013 Year 05 Month 13 Day
Anticipated trial start date	2013 Year 05 Month 15 Day
Last follow-up date	2018 Year 08 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 05 Month 14 Day
Last modified on	2019 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012522