UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Clinical Trial of Gemcitabine and Irinotecan for Unresectable and Recurrent Pancreatic Cancer
Title of the study (Brief title)	Phase II Tial of Gem+CPT-11 for Unresectable PC
Region	Japan

Condition
Condition	Unresectable or Recurrent Pancreatic Cancer (PC)
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the Safety and Efficacy of Gemcitabine and Irinotecan for PC
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Safety PFS OS

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Gemcitabine 1,000mg/m2 and Irinotecan 100mg/m2 are administered with intravenous infusion on day 1 and 15 every 4 weeks.
Interventions/Control_2
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	40

Research contact person
Name of lead principal investigator	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and CVD
Division name	Hepatobiliary and Pancreatic Oncology
Address	Nakamichi 1-3-3, Higashinari-ku Osaka
TEL	06-6972-1181
Email	ioka_ta@hotmail.com

Public contact
Name of contact person	Tatsya Ioka
Organization	Osaka Medical Center for Cancer and CVD
Division name	Hepatobiliary and Pancreatic Oncology
Address	Nakamichi 1-3-3, Higashinari-ku, Osaka, 5378511, Japan
TEL	06-6972-1181
Homepage URL
Email	ioka_ta@hotmail.com

Sponsor
Institute	Osaka Medical Center for Cancer and CVD
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	2013 Year 02 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2002 Year 04 Month 01 Day
Anticipated trial start date	2004 Year 04 Month 01 Day
Last follow-up date	2007 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 02 Month 05 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=R000011666