UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009831 |
|---|---|
| Receipt number | R000011517 |
| Scientific Title | A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2019/12/27 15:42:03 |
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Basic information
Public title
A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Acronym
A multicenter phase II trial of pre-operative chemotherapy with GCS for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Scientific Title
A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Scientific Title:Acronym
A multicenter phase II trial of pre-operative chemotherapy with GCS for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Region
| Japan |
Condition
Condition
biliary tract cancers
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety
of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Curative 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
Pre-operative chemotherapy (GCS) 3 cycles-FDG-PET-surgery
GCS therapy
Gemcitabine 1000mg/m2/day1
Cisplatin 25mg/m2/day1
S-1 100mg/body/day1-7
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 radiologically proven bilialy tract cancer.
2.No extrahepatic disease.
3.No prior therapy.
4.The function of the liver is kept as satisfied after hepatectomy.
5.No chronic liver damage.
6.Patients of age over 20 years.
7.ECOG performance status of 0-1.
8.Sufficient organ function.
9.Patients obtained written informed consent.
Key exclusion criteria
1. Massive abdominal effusion requiring treatment.
2. Active concomitant malignancy.
3. The case suspected of infection.
4. Patients with water solubility diarrhea.
5. Mental disease or psychotic manifestation.
6. Under continuous steroid therapy.
7. Patients with acute myocardial infaction.
8. Patients with severe complications.
9. Pregnancy or the desire to preserve fecundity.
10. Serious drug hypersensitivity or a history of drug allergy.
11. Any patients judged by the investigator to be unfit to participate in the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuro Hatano |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Seo |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL
075-751-3242
Homepage URL
rutosa@kuhp.kyoto-u.ac.jpKH
Sponsor or person
Institute
KHBO
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 21 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011517
