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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009739
Receipt No. R000011415
Scientific Title biweekly irinotecan monotherapy for refractory advanced pancreatic cancer
Date of disclosure of the study information 2013/01/10
Last modified on 2017/05/31

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Basic information
Public title biweekly irinotecan monotherapy for refractory advanced pancreatic cancer
Acronym biweekly irinotecan monotherapy for refractory advanced pancreatic cancer
Scientific Title biweekly irinotecan monotherapy for refractory advanced pancreatic cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroyuki Isayama
Organization The University of Tokyo
Division name Department of Gastroenterology, Graduate School of Medicine
Zip code
Address 7-3-1, Hongo, Bunkyo-ku Tokyo
TEL 03-3815-5411
Email isayama-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Isayama
Organization The University of Tokyo
Division name Department of Gastroenterology, Graduate School of Medicine
Zip code
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)

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
2013 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2013 Year 01 Month 08 Day
Date of IRB
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

Other
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

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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