UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.
Title of the study (Brief title)	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	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Medical Oncology
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	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Medical Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 10 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000002629