UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009739 |
|---|---|
| Receipt number | 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 18:30:38 |
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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
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
isayama-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011415
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
