UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000974 |
|---|---|
| Receipt number | 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 19:45:24 |
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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
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
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001169
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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