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Recruitment status Terminated
Unique ID issued by UMIN UMIN000003269
Receipt No. R000003958
Scientific Title Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
Date of disclosure of the study information 2010/03/01
Last modified on 2013/10/01

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Basic information
Public title Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
Acronym Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
Scientific Title Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
Scientific Title:Acronym Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
Region
Japan

Condition
Condition pancreatic cancer with ascites
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 efficacy and safety of gemicitabin plus S-1 for advanced pancreatic cancer patients with ascites.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes adverse events, response rate, progression free survival, efficacy against ascites

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 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
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) Pancreatic cancer histologically confirmed as adenocarcinoma or adenosquamous carcinoma.
2) Patients with mild or moderate ascites.
3) Patients with no previous treatment for pancreatic cancer, except resection.
4) Age: 20 years to less than 80 years.
5) ECOG Performance Status(PS) of 0 or 1.
6) Adequate organ functions.
7) Sufficient oral intake.
8) Written informed consent.
Key exclusion criteria 1) Interstitial pneumonia or fibroid lung.
2) Watery diarrhea.
3) Active infection, excluding viral hepatitis.
4) Serious complications (e.g. heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
5) Ascites only localized at pelvic cavity.
6) Massive ascites.
7) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 1 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration.
8) Sever ECG abnormality.
9) Patients under treatment with flucytosine, phenytoin or warfarin potassium.
10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
11) Sever mental disorder.
12) Inadequate physical condition, as diagnosed by primary physician.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Msafumi Ikeda
Organization National Cancer Center Hospital East
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Shimizu
Organization National Cancer Center Hospital East
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email sashimiz@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Hepatobiliary and Pancreatic Oncology Division
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 国立がんセンター東病院(千葉県)
国立がんセンター中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 03 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 Terminated
Date of protocol fixation
2009 Year 11 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 02 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
2010 Year 03 Month 01 Day
Last modified on
2013 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003958

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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