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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007556
Receipt No. R000008872
Scientific Title A phase 1 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer
Date of disclosure of the study information 2012/03/23
Last modified on 2014/09/23

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

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

Objectives
Narrative objectives1 We will investigate the safety of combination therapy with gemcitabine and S-1 and leucovorin and determine the maximum tolerated dose and the recommended dose.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Dose limiting toxicity, maximum tolerated dose, recommended dose
Key secondary outcomes Response rate, disease control rate, progression free survival, overall survival, 1-year survival rate, feasibility, safety

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 a combination therapy with gemcitabine, S-1 and leucovorin
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 < 10,000/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 18

Research contact person
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 03-3815-5411
Email isayama-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yousuke Nakai
Organization University of Tokyo
Division name Gastroenterology
Zip code
Address 7-3-1 Hongo Bunkyo-ku Tokyo
TEL 03-3815-5411
Homepage URL
Email ynakai-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo, Department of Gastroenterology
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
2012 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25143299
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 Main results already published
Date of protocol fixation
2012 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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
2012 Year 03 Month 23 Day
Last modified on
2014 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008872

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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