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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000974
Receipt No. R000001169
Scientific Title A randomized phase II study designed to compare toxicity and dose intensity between four-week versus three-week schedule of gemcitabine for advanced pancreatic cancer
Date of disclosure of the study information 2008/01/08
Last modified on 2008/01/08

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Basic information
Public title A randomized phase II study designed to compare toxicity and dose intensity between four-week versus three-week schedule of gemcitabine for advanced pancreatic cancer
Acronym Four-week versus three-week schedule of gemcitabine for advanced pancreatic cancer
Scientific Title A randomized phase II study designed to compare toxicity and dose intensity between four-week versus three-week schedule of gemcitabine for advanced pancreatic cancer
Scientific Title:Acronym Four-week versus three-week schedule of gemcitabine for advanced pancreatic cancer
Region
Japan

Condition
Condition Advanced nonresectable 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 compare toxicity and dose intensity between four-week and three-week schedule of gemcitabine for advanced pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Compliance rate of protocol regimen (The rate is the proportion of patients without grade 3 to 4 hematological toxicity or grade 2 to 4 non-hematological toxicity defined by Common Terminology Criteria for Adverse Events (CTCAE) ver3.0, within eight weeks after initiation of chemotherapy. )
Key secondary outcomes Dose intensity
1 year survival rate
Median survival time
Response Rate
Time to progression
Time to treatment failure
Karnofsky - perfomance status
Adverse effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1, 8 and 15. The cycle was repeated every four weeks until evidence of disease progression, patient refusal or unacceptable toxicity.
Interventions/Control_2 Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1 and 8. The cycle was repeated every three weeks until 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
80 years-old >=
Gender Male and Female
Key inclusion criteria The study is designed to enroll patients with nonresectable, histologically or cytologically proven, locally advanced or metastatic pancreatic adenocarcinoma. Other eligibility criteria includes no prior therapy, Karnofsky Performance Status >= 50%, age between 20 and 80 years, life expectancy more than 2 months, and adequate organ function defined as WBC >=3,000/mm3, neutrophils >=1,500/mm3, platelets >=100,000/mm3, hemoglobin>=9.0g/dl, total bilirubin <=2.0mg/dl (or <=3.0mg/dl if biliary drainage were present), AST and ALT <=2 times the upper limit of normal (or <=5 times the upper limit of normal if liver metastasis were present), and creatinine <= the upper limit of normal. Written informed consent is required from all patients.
Key exclusion criteria The exclusion criteria are as follows: active infection, intestinal pneumoniae or lung fibrosis, severe complication such as liver cirrhosis and heart disease, active concomitant malignancy, pregnant or lactating females, females of childbearing age, sever drug hypersensitivity, and the patient inappropriate for entry onto this study in the judgment of the investigator.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Kawamoto
Organization Okayama University Hospital
Division name Departments of Gastroenterology
Zip code
Address 2-5-1 Shikata-cho, Okayama 700-8558, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Okayama University Hospital
Division name Departments of Gastroenterology
Zip code
Address 2-5-1 Shikata-cho, Okayama 700-8558, Japan
TEL
Homepage URL
Email

Sponsor
Institute Okayama University 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

Other administrative information
Date of disclosure of the study information
2008 Year 01 Month 08 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
Date of protocol fixation
2006 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2008 Year 12 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
2008 Year 01 Month 08 Day
Last modified on
2008 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001169

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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