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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002154
Receipt No. R000002629
Scientific Title Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.
Date of disclosure of the study information 2009/07/02
Last modified on 2017/05/16

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Basic information
Public title Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.
Acronym Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.
Scientific Title Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.
Scientific Title:Acronym Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.
Region
Japan

Condition
Condition Patients with gemcitabine-refractry advanced pancreatic cancer.
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy and toxicity of 2nd line therapy against gemcitabine-refractory advanced pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Median Survival Time of 2nd line therapy
Key secondary outcomes Clinical Benefit Response (CBR)
Safety
Time To Progression (TTP)
Overall Survival (OS)

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 Group A : Gemcitabine 1,000mg/m2 is administered with for 30-min intravenous infusion on day 1, 8 and 15 every 4 weeks.
Interventions/Control_2 Group B : Best available fluoropyrimidine therapy : Each institute can choose following available treatment therapy.
1) UFT therapy : UFT 400 mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks.
2) 5-FU therapy : 5-FU 600mg/m2 is administered with 60-min intravenous infusion on day 1, 8 and 15 every 4 weeks.
3) TS-1 therapy : TS-1 80 mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks.

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) Histologically confirmed pancreatic ductal carcinoma.
2) Patients of age =>20 and 80>
3) Performance Status:0-2(ECOG)
4) Life expectancy more than 1 months.
5) Adequate organ functions.
neutrophils >=2,000/mm3
leukocytes =>4,000 and 12,000/mm3>
platelets >=100,000/mm3
hemoglobin >=9.5g/dl
AST(GOT)/ALT(GPT) <=LLN x2.5
total bilirubin <=LLN x2
serum creatinine <= LLN
BUN <= LLN
PaO2 >= 70 torr
6) Written informed consent.

Key exclusion criteria 1) Lung fibrosis or intestinal pneumoni, and anamnesis or imaging findings.
2) Severe infection.
3) Severe complication.
(heart failure, angina pectoris, arrhythmia, diabetes , intestines paralysis, ileus, myocardial infarction within 6 months after the onset.)
4) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy.
5) Watery diarrhea.
6) Jaundice.
7) Uncontrolled pleural or abdominal effusion.
8) Severe drug hypersensitivity.
9) History of other active malignancy.
10) Severe mental illness
11) Patients who are judged inappropriate for the entry into the study by the investigater.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Ioka
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Medical Oncology
Zip code
Address 3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL 06-6945-1181
Email ioka_ta@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Ioka
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Medical Oncology
Zip code
Address 3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL 06-6972-1181
Homepage URL
Email ioka-ta@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology
Pancreatic cancer study Group
Institute
Department

Funding Source
Organization Osaka foundation for the prevention of cancer and cardiovascular diseases
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 07 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2005 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 02 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 02 Day
Last modified on
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002629

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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