UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003650 |
|---|---|
| Receipt number | R000004419 |
| Scientific Title | Phase II study of gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced biliary tract cancer (JASPAC02) |
| Date of disclosure of the study information | 2010/05/21 |
| Last modified on | 2013/11/23 13:28:25 |
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Basic information
Public title
Phase II study of gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced biliary tract cancer (JASPAC02)
Acronym
Phase II study of gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced biliary tract cancer (JASPAC02)
Scientific Title
Phase II study of gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced biliary tract cancer (JASPAC02)
Scientific Title:Acronym
Phase II study of gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced biliary tract cancer (JASPAC02)
Region
| Japan |
Condition
Condition
gemcitabine refractory advanced biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced biliary tract cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
adverse events
serious adverse events
progression-free survival
overall survival
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
Gemcitabine (1,000mg/m2, div, over 100 minutes, day1), Oxaliplatin (100mg/m2, div, over 120 minutes, day1), every 2 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
| 79 | years-old | >= |
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) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma
4) Refractory to one prior gemcitabine based chemotherapy
5) No previous therapy against biliary tract cancer
6) No previous chemotherapy or radiotherapy against any other malignancies within 3 years
7) Measurable disease as defined by Revised RECIST guideline (version 1.1)
8) At least 2 weeks have passed after the prior therapy
9) ECOG PS of 0 or 1
10) At least eight-week life expectancy
11) Without CNS metastasis
12) Without moderate or more ascites/pleural effusion
13) Sufficient oral intake
14) Aged 20 to 79 years old
15) Adequate organ functions
16) Written informed consent
Key exclusion criteria
1) Prior history of chemotherapy with oxaliplatin
2) Grade >= 2 sensory neuropathy
3) Plumonary fibrosis or interstitial pneumonia
4) Uncontrollable watery diarrhea
5) NYHA III or IV cardiac function
6) Myocardial infarction within six months
7) Active bacterial or fungous infection
8) Uncontrollable diabetes millitus
9) Blood transfusion within two weeks
10) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc
11) Psychosis or severe mental disorder
12) Severe drug allergy
13) Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy
14) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant
15) Patients requiring systemic steroids medication
16) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy
17) Inadequate physical condition, as diagnosed by primary physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Fukutomi |
Organization
Shizuoka Cancer Center
Division name
Division of GI Oncology
Zip code
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Fukutomi |
Organization
JASPAC02 Coordinating Office
Division name
Shizuoka Cancer Center, Division of GI Oncology
Zip code
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL
055-989-5222
Homepage URL
Sponsor or person
Institute
Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Institute
Department
Personal name
Funding Source
Organization
Pharma Valley Center, the Shizuoka Organization for Creation Industries
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
杏林大学医学部付属病院（東京都）
神戸大学医学部附属病院（兵庫県）
国立がん研究センター中央病院（東京都）
国立がん研究センター東病院（千葉県）
国立病院機構大阪医療センター（大阪府）
埼玉県立がんセンター（埼玉県）
癌研究会有明病院（東京都）
静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://eccamsterdam2013.ecco-org.eu/Scientific-Programme/Abstract-search.aspx?abstractid=6112
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
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 21 | Day |
Last modified on
| 2013 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004419
