UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029490 |
|---|---|
| Receipt number | R000033693 |
| Scientific Title | Phase I / II Study of GEM/Cisplatin/nab-PTX for Biliary tract cancer with pathological lymph node metastasis |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2017/10/10 14:48:41 |
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Basic information
Public title
Phase I / II Study of GEM/Cisplatin/nab-PTX for Biliary tract cancer with pathological lymph node metastasis
Acronym
GCA for advanced BTC
Scientific Title
Phase I / II Study of GEM/Cisplatin/nab-PTX for Biliary tract cancer with pathological lymph node metastasis
Scientific Title:Acronym
GCA for advanced BTC
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine recommended dose and to evaluate feasibility and efficacy of GEM/CDDP/nab-PTX treatment for biliary tract cancers with regional pathological lymph node metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase I: Feasibilty (MTD and RD)
Phase II: Response rate, Tumor control rate, Resectability and R0 resection rate
Key secondary outcomes
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
gemcitabine 600, 800, 1000 mg/m2
cisplatin 25 mg/m2
nab-PTX 80, 100, 125 mg/m2
day 1 and8, every 3 weeks
2 cycles.
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) PS 0-1
2) no impairment of bone marrow, liver, renal, cardiac, and pulmonary function:
2-a) neutrophil >= 2000/mm3
2-b) platelet >= 100,000/mm3
2-c) hemoglobin >= 9.0 g/dL
2-d) bilirubin <= 2.0 mg/dL
2-e) AST, ALT <= 5 x UNL
2-f) creatinine <= 1.5 mg/dL
3) written informed consent
Key exclusion criteria
1) distant metastasis
2) estimated remnant liver volume after PTPE would become under 35% because the measurement includes resectability
3) active cancers, without carcinoma in situ
4) suspected or definitive pulmonary fibrosis or interstitial pneumonia
5) watery diarrhea
6) active infection without viral hepatitis nor cholangitis
7) severe complications: cardiac, renal, liver failure, bleeding peptic ulcer, bowel paralysis, bowel obstruction, uncontrollable diabetes mellitus
8) pregnancy
9) severe mental disorder
10) severe allergy
11) entry on other studies
12) inappropriate by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Surgery
Zip code
Address
2-2(E2) Yamadaoka, Suita city, Osaka 565-0871, Japan
TEL
+81-6-6879-3251
s-kobayashi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Kobayashi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Surgery
Zip code
Address
2-2(E2) Yamadaoka, Suita city, Osaka 565-0871, Japan
TEL
+81-6-6879-3251
Homepage URL
s-kobayashi@umin.ac.jp
Sponsor or person
Institute
Osaka Univiersity
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2017 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | 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
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033693
