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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007173
Receipt No. R000008441
Scientific Title Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer
Date of disclosure of the study information 2012/02/01
Last modified on 2012/01/31

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Basic information
Public title Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer
Acronym Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer
Scientific Title Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer
Scientific Title:Acronym Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer
Region
Japan

Condition
Condition 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 a gemicitabin plus S-1and S-1 alone as a second-line treatment for gemcitabine-refractory 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 response rate, overall survival, adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
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 A: Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S-1(60-100 mg/day, day1-14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
Interventions/Control_2 B: Patients receive S-1 alone (80-120 mg/day, day1-28 every 6 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)Diagnosed as pancreatic cancer
2)Recurrent or unresectable pancreatic cancer
3)Histologically proven invasive ductal pancreatic cancer
4)Refractory to gemcitabine monotherapy or gemcitabine combination therapy exclusive 5-FU chemotherapy (recurrent within 6 months after gemcitabine adjuvant therapy is eligible)
5)Gemcitabine chemotherapy over 4weeks
6)ECOG PS of 0,1 or 2
7)Sufficient oral intake
8)Aged over 20 years old
9)Adequate organ functions
10)Written informed consent
Key exclusion criteria 1)With moderate or more pleural effusion/ ascites
2)Interstitial pneumonia or fibroid lung
3)Cardiac insufficiency or myocardial infarction within six months
4)Active bacterial or fungous infection
5)Uncontrollable diabetes mellitus
6)Psychosis or severe mental disorder
7)Severe drug allergy
8)Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy
9) Previous chemotherapy or radiotherapy against any other malignancies within 3 years
10)Over 6 months after adjuvant gemcitabine chemotherapy
11)With CNS metastas
12)Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
13)Pregnant, lactating women or women of childbearing potential
14)Men who want to get partner pregnant
15)Inadequate physical condition, as diagnosed by primary physician
Target sample size 90

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tetsuya Mine
Organization Tokai University Hospital
Division name Division of medical gastroenterology
Zip code
Address 143 Shimokasuya Isehara city
TEL 0463-93-1121
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Makoto Ueno
Organization Kanagawa Cancer Center
Division name Division of hepatobiliary and pancreatic medical oncology
Zip code
Address 1-1-2 Nakao Asahi-ku Yokohama City
TEL 045-391-5761
Homepage URL
Email kantansui@kcch.jp

Sponsor
Institute Tokai University Hospital
Kanagawa Cancer Center
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

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 01 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 Open public recruiting
Date of protocol fixation
2011 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2015 Year 02 Month 01 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 01 Month 31 Day
Last modified on
2012 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008441

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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