UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007454
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email toyokawh@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Hepatobiliary Oncology Group (KHBO)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008786

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.