UMIN-CTR Clinical Trial

Basic information
Public title	A Phase I study of adjuvant chemotherapy with gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy
Acronym	A Phase I study of adjuvant chemotherapy with GC in biliary tract cancer undergoing resection without major hepatectomy
Scientific Title	A Phase I study of adjuvant chemotherapy with gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy
Scientific Title:Acronym	A Phase I study of adjuvant chemotherapy with GC 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 cisplatin 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 cisplatin 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 othe than surgery 6) No dyfunction 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) Patiens with active infectious disease 6) Pregnancy 7) Patients with severe psychological disease 8) Patients seems inadequate for this study by investigators
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tetsuo Ajiki
Organization	Kobe University Graduate School of Medicine
Division name	Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-6302
Email	ajiki@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tetsuo Ajiki
Organization	Kobe University Graduate School of Medicine
Division name	Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-6302
Homepage URL
Email	ajiki@med.kobe-u.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	2011 Year 01 Month 01 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	Main results already published
Date of protocol fixation	2011 Year 01 Month 01 Day
Date of IRB	2010 Year 12 Month 28 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2014 Year 12 Month 31 Day
Date of closure to data entry	2014 Year 12 Month 31 Day
Date trial data considered complete	2014 Year 12 Month 31 Day
Date analysis concluded	2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2010 Year 11 Month 25 Day
Last modified on	2020 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005515