UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002154 |
|---|---|
| Receipt number | 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 19:12:43 |
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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
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
ioka-ta@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology
Pancreatic cancer study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002629
