UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006123 |
|---|---|
| Receipt number | R000007244 |
| Scientific Title | Phase I study of Gemcitabine, Cisplatin and S-1 for advanced biliary tract cancer. |
| Date of disclosure of the study information | 2011/08/17 |
| Last modified on | 2015/02/05 09:25:56 |
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Basic information
Public title
Phase I study of Gemcitabine, Cisplatin and S-1 for advanced biliary tract cancer.
Acronym
Phase I study of Gemcitabine, Cisplatin and S-1 for advanced biliary tract cancer. (GPS-P1 study)
Scientific Title
Phase I study of Gemcitabine, Cisplatin and S-1 for advanced biliary tract cancer.
Scientific Title:Acronym
Phase I study of Gemcitabine, Cisplatin and S-1 for advanced biliary tract cancer. (GPS-P1 study)
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and determine the recommended dose
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Recommended dose
Key secondary outcomes
Dose-limiting toxicity, maximum tolerated dose, toxicity, relative dose intensity, tumor response, progression-free survival, and overall survival
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
S-1: 80 mg/m2 (Day 1-7)
GEM: dose escalation (Day 1)
CDDP: 30 mg/m2 (Day 1)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with pathologically proved biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer
2.No prior history of chemotherapy. Patient who has undergone adjuvant chemotherapy are eligible if at least 6 months has passed since the last administration.
3.Performance Status (ECOG): 0-2
4.Survival is expected over 3 months
5.Adequate organ function
6.Age >= 20 years
7.Provided written informed consent
8.Measurable or evaluable lesion
Key exclusion criteria
1.With a history of severe drug allergy
2.Active infection
3.Sever complication
4.With uncontrollable diabetes mellitus (HbA1C >=8.0%)
5.With steroid
6.With interstitial pneumonia or pulmonary fibrosis
7.With severe pleural effusion or ascites
8.Active double cancer
9.Patients who are pregnant or lactating, or have an intention to get pregnant
10.Inadequate physical condition, as diagnosed by primary physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichinosuke Hyodo |
Organization
Tsukuba University Hospital
Division name
Divison of Gastroenterology
Zip code
Address
2-1-1 Amakubo, Tsukuba-shi, Ibaraki-ken, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshikazu Moriwaki |
Organization
Tsukuba University Hospital
Division name
Divison of Gastroenterology
Zip code
Address
2-1-1 Amakubo, Tsukuba-shi, Ibaraki-ken, Japan
TEL
Homepage URL
tmoriwak@md.tsukuba.ac.jp
Sponsor or person
Institute
Tsukuba University Hospital, Division of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Tsukuba Cancer Clinical Trial Group (TCTG)
Organization
Division
Category of Funding Organization
Other
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
筑波大学附属病院（茨城県）、茨城県立中央病院（茨城県）、水戸医療センター（茨城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 05 | Day |
Last modified on
| 2015 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007244
