UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005918 |
|---|---|
| Receipt number | R000006999 |
| Scientific Title | Phase 2 study of fix dose rate gemcitabine plus S-1 with advanced biliary tract cancer refractory to standard dose rate gemcitabine |
| Date of disclosure of the study information | 2011/07/05 |
| Last modified on | 2017/07/10 16:08:10 |
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Basic information
Public title
Phase 2 study of fix dose rate gemcitabine plus S-1 with advanced biliary tract cancer refractory to standard dose rate gemcitabine
Acronym
Phase 2 study of fix dose rate GEM plus S-1 with advanced BTC refractory to GEM
Scientific Title
Phase 2 study of fix dose rate gemcitabine plus S-1 with advanced biliary tract cancer refractory to standard dose rate gemcitabine
Scientific Title:Acronym
Phase 2 study of fix dose rate GEM plus S-1 with advanced BTC refractory to GEM
Region
| Japan |
Condition
Condition
Advanced biliary tract cancer refractory to standard rate gemcitabine
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objects of this study is to evaluate the efficacy and safety of fix dose rate gemcitabine plus S-1 with advanced biliary tract cancer refractory to standard rate gemcitabine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Reponse rate
Key secondary outcomes
Overall survival
Progression-free survival
Adverse events
Serious 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
Gemcitabine(1000mg/m2, div, over 100 minutes, day1), S-1(40mg/m2 twice daily, oral, day1-7), every two weeks. Treatment is repeated until disease progression, patient's refusal, or serious adverse event.
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) 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) Measurable disease as defined by Revised RECIST guideline (version 1.1)
5) Without CNS metastasis
6) Without moderate or more ascites/pleural effusion
7) Refractoy to one prior gemcitabine or gemcitabine based chemotherapy, defined by RECIST version 1.1
8) No previous therapy against biliary tract cancer
9) No previous chemotherapy or radiotherapy against any other malignancies within 3 years
10) ECOG PS of 0, 1, 2
11) Sufficient oral intake
12) Aged 20 years old or over
13) At least 2 weeks have passed after the prior therapy
14) Adequate organ function
15) Written informed consent
Key exclusion criteria
1) Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy
2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant
3) Psychosis or severe mental disorder
4) Patients requiring systemic steroids medication
5) Plumonary fibrosis or interstitial pneumonia
6) Uncontrollable watery diarrhea
7) Active bacterial or fungous infection
8) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, uncontrollable diabetes millitus etc
9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
10) Patients who can't receive neither iodic drug nor gadolinium because of drug allergy
11) Prior history of chemotherapy with pyrimidine fluoride for the other disease within the 5 years
12) 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 | Shinichi Ohkawa |
Organization
Kanagawa Cancer Center
Division name
Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address
2-3-2, Nakao, Asahi Ward, Yokohama
TEL
045-520-2222
s-ohk@kcch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kobayashi |
Organization
Kanagawa Cancer Center
Division name
Division of Hepatobiliary and Pancreas Oncology
Zip code
Address
2-3-2, Nakao, Asahi Ward, Yokohama
TEL
045-391-5761
Homepage URL
kobayashis@kcch.jp
Sponsor or person
Institute
Yokohama Clinical Oncology Group
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
神奈川県立がんセンター（神奈川県）
横浜市立大学付属市民総合医療センター（神奈川県）
国立国際医療研究センター（東京都）
国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://meetinglibrary.asco.org/content/157741-173
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
Main results already published
Date of protocol fixation
| 2011 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 05 | Day |
Last modified on
| 2017 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006999
