UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	biweekly irinotecan monotherapy for refractory advanced pancreatic cancer
Title of the study (Brief title)	biweekly irinotecan monotherapy for refractory advanced pancreatic cancer
Region	Japan

Condition
Condition	advanced pancreatic cancer refractory to chemotherapy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	safety and efficacy of biweekly irinotecan monotherapy in refractory advanced pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	response rate, disease control rate, progression free survival, 1-year survival rate, adverse events

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	irinotecan div day 1 and 15 in a 4-week course
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with advanced or recurrent pancreatic cancer 2) Patients with pathologically confirmed pancreatic cancer 3) Patients refractory to gemcitabine and S-1 4) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 5) Patients of age >= 20 years 6) Patients have an adequate organ function 6) Patients have an ability for a sufficient oral intake 7) Written informed consent is required from all patients
Key exclusion criteria	1) Patients with active infection 2) Patients with active GI bleeding 3) Patients with intestinal pneumonia, pulmonary fibrosis, and severe pulmonary emphysema 4) Patients with uncontrolled pleural effusion or ascites 5) Patients with watery diarrhea or ileus 6) Patients with synchronous or metachronous concomitant malignancies 7) Pregnant or lactating female or patients who are considering pregnancy 8) Patients with contraindication to irinotecan 9) Patients who are actively on other anticancer treatment 10) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size	53

Research contact person
Name of lead principal investigator	Hiroyuki Isayama
Organization	The University of Tokyo
Division name	Department of Gastroenterology, Graduate School of Medicine
Address	7-3-1, Hongo, Bunkyo-ku Tokyo
TEL	03-3815-5411
Email	isayama-tky@umin.ac.jp

Public contact
Name of contact person	Hiroyuki Isayama
Organization	The University of Tokyo
Division name	Department of Gastroenterology, Graduate School of Medicine
Address	7-3-1, Hongo, Bunkyo-ku Tokyo
TEL	03-3815-5411
Homepage URL
Email	isayama-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

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)

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 01 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 01 Month 08 Day
Anticipated trial start date	2013 Year 01 Month 10 Day
Last follow-up date
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 01 Month 10 Day
Last modified on	2017 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011415