UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006047 |
|---|---|
| Receipt number | R000004626 |
| Scientific Title | Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2014/02/07 09:39:51 |
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Basic information
Public title
Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
Acronym
Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
Scientific Title
Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
Scientific Title:Acronym
Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
Region
| Japan |
Condition
Condition
cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of 3rd-line Panitumumab for gemcitabin, TS-1, CDDP tolerant unresectable or recurrent cholangiocarcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
response rate (CR+PR)
Key secondary outcomes
Severe adverse events
Progression free survival (PFS)
Time to progression (TTP)
Overall survival (OS)
Median survival time (MST)
Disease control rate (DCR)
adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Biweekly administration of Panitumumab (6mg/kg, div, over 1hr), evaluation of adverse effect grade with NCI-CTC ver.4 and its frequency. administration is continued untill tumor progression is detected (RECIST ver. 3.1).
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) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer
(2)Recurrent or unrespectable biliary tract cancer
(3)Refractory to prior both gemcitabine, TS-1 and CDDP based chemotherapy
(4)Measurable disease as defined by Revised RECIST guideline (version 1.1)
(5)ECOG PS of 0 or 1
(6)No severe organ function impairment
(7)Life expectancy > 3 months
(8)Sufficient oral intake
(9)Written informed consent
(10)Aged over 20 with judgment
Key exclusion criteria
(1)Previous history of chemotherapy with anti-EGFR antibody
(2)Tumor is controllable with any other therapy (SD, PR, CR, NE in RECIST ver.1.1)
(3)Previous history of infusion reaction by antibody drug
(4)Serious complications (e.g. severe hypertension, severe heart failure, severe coronary artery disease, myocardial infarction within 3 months, severe hepatic failure, poorly controlled diabetes, plumonary fibrosis, interstitial pneumonia or renal failure with dialysis)
(5) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
(6)Pregnant or lactating women or women of childbearing potential (restrict lactating within 8 weeks after last Panitmumab administration)
(7)Patient with severe drug allergy
(8)Psychosis or severe mental disorder
(9)Inadequate physical condition, as diagnosed by primary physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7205
hiroki@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7205
Homepage URL
hiroki@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Hepato-Biliary Pancreatic Surgery
, Tohoku University Hospital
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 26 | Day |
Last modified on
| 2014 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004626
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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| Registered date | File name |
