UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II study of Gemcitabine and S-1 combination therapy versus S-1 in patients with Gemcitabine-refractory unresectable advanced Pancreatic Cancer
Acronym	Randomized phase II study of GS vs. S-1 in patients with Gem-refractory unresectable advanced Pancreatic Cancer
Scientific Title	Randomized phase II study of Gemcitabine and S-1 combination therapy versus S-1 in patients with Gemcitabine-refractory unresectable advanced Pancreatic Cancer
Scientific Title:Acronym	Randomized phase II study of GS vs. S-1 in patients with Gem-refractory unresectable advanced Pancreatic Cancer
Region	Japan

Condition
Condition	unresectable advanced Pancreatic Cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate safety and efficacy of GS and S-1 as a second-line treatment for Gem-refractory unresectable advanced pancreatic cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Overall survival, Disease Control Rate, Response Rate, Relative Dose Intensity, Adverse Events, Time to Treatment failure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
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	Control arm:S-1 q6w Patients receive S-1 alone (80-120mg/day, day1-28) every 6 weeks. It is repeated until obvious evidence of Disease Progression, patient refusal, or unacceptable toxicity.
Interventions/Control_2	Testing arm:Gem+S-1 q4w Patients receive S-1(80-120mg/day, day1-21) plus Gemcitabine(800mg/m2, day1,15) every 4 weeks. It is repeated until obvious evidence of Disease Progression, patient refusal, or unacceptable toxicity.
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)Unresectable pancreatic cancer(without Recurrent cancer) 2)Age 20- 3)PS(ECOG) 0-1 4)Refractory Gem monotherapy or Gem combination therapy 5)Over 2 weeks after previous Gem chemotherapy 6)Sufficient oral intake 7)Metastatic pancreatic adenocarcinoma with measurable lesion according to RECSTver 1.1 8)Biliary drainage was applied adequately in patients with obstructive jaundice 9)Adequate organ functions 10)Written informed consent
Key exclusion criteria	1)Patients who have previously administered 5-FU including S-1 2)Severe complications 3)Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 4)Severe Gem hypersensitivity 5)Patients who have not undergone radiotherapy 6)Active infections 7)Patients with HBs antigen-positive or with HCV antibody-positive 8)Patients who have previous history of radiotherapy to the chest 9)Uncontrollable watery diarrhea 10)Presence of metastasis in central nervous system 11)Severe mental disorders 12)Pregnant or lactating women, or women with known or suspected pregnancy and men who want let to pregnancy 13)Required to continue to take flucytosine, phenytoin, and warfarin 14)Patients seems inadequate for this study by investigators
Target sample size	116

Research contact person
Last name of lead principal investigator	1st name Tetsuo Middle name Last name Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL	06-6879-3621
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
1st name of contact person	1st name Minoru Middle name Last name Shigekawa
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	5650871
Address	2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL	06-6879-3621
Homepage URL
Email	m-shigekawa@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka Pancreas Forum
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	Osaka University
Address	2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
Tel	06-6879-3621
Email	m-shigekawa@gh.med.osaka-u.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	2013 Year 09 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	49
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	2013 Year 09 Month 19 Day
Date of IRB	2013 Year 09 Month 19 Day
Anticipated trial start date	2013 Year 09 Month 20 Day
Last follow-up date	2018 Year 03 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	2013 Year 09 Month 19 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013805