UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007454 |
|---|---|
| Receipt number | R000008786 |
| Scientific Title | A Phase I study of adjuvant chemotherapy with gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2013/10/30 14:42:14 |
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Basic information
Public title
A Phase I study of adjuvant chemotherapy with gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy
Acronym
A Phase I study of adjuvant chemotherapy with GS in biliary tract cancer undergoing resection without major hepatectomy
Scientific Title
A Phase I study of adjuvant chemotherapy with gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy
Scientific Title:Acronym
A Phase I study of adjuvant chemotherapy with GS in biliary tract cancer undergoing resection without major hepatectomy
Region
| Japan |
Condition
Condition
Biliary tract cancer undergoing curative resection without major hepatectomy
Classification by specialty
| Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To decide MTD and RD of treatment using gemcitabine plus S-1 combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum tolerated dose, recommended dose
Key secondary outcomes
Toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dose of gemcitabine and S-1 and treatment schedule
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) Biliary tract cancer (BTC) with more than stage IB
2) BTC undergoing R0 or R1 resection without major hepatectomy
3) Older than 20 years old
4) PS0 or 1
5) No treatment other than surgery
6) No dysfunction of main organs
7) Possible oral intake
8) Treatment start; after 4 weeks and within 12 weeks after surgery
9) Obtained written informed consent
Key exclusion criteria
1) Patients with resection of major hepatectomy
2) Patients with double cancers
3) Patients having severe allergy
4) Patients with severe organ dysfunction
5) Patients with active infectious disease
6) Pregnancy
7) Patients with severe psychological disease
8) Patients seem inadequate for this study by investigators
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyoshi Toyokawa |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata City, Osaka
TEL
072-804-0101
toyokawh@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyoshi Toyokawa |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata City, Osaka
TEL
072-804-0101
Homepage URL
toyokawh@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Hepatobiliary Oncology Group (KHBO)
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | 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
| 2012 | Year | 03 | Month | 06 | Day |
Last modified on
| 2013 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008786
