UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer
Title of the study (Brief title)	Bile Duct Cancer Adjuvant Trial (BCAT)
Region	Japan

Condition
Condition	Bile duct cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of the present study is to evaluate efficacy of adjuvant chemotherapy using gemcitabine in patients underwent R0/R1 resection for bile duct cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Over All Survival Time
Key secondary outcomes	Adverse Events, Recurrence Free Survival Time

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Adjuvant chemoterapy with gemcitabine
Interventions/Control_2	Observation following surgery
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Adenocarcinoma; Extrahepatic bile duct carcinoma or hilar type intrahepatic cholangiocarcinoma 2. UICC stage I or II or III, R0 or R1 3. ECOG PS 0 or 1 4. No chemotherapy or radiotherapy in the past 5 years 5. 3000/mm3<=WBC<=12000/mm3, Plt>=100000/mm3, Hb=>8.0 g/dL, T.Bil<=2.0mg/dL, AST<=100IU/L, ALT<=100IU/L, Cre<=1.5mg/dL
Key exclusion criteria	1. Pleural effusion or ascites, moderate amount 2. Pericardial effusion 3. NYHA class III or IV 4. Myocardiac infarction in the past 3 months 5. Active viral hepatitis 6. Uncontrolled Diabetes Melitus 7. Blood trasfusion in the past 2 weeks
Target sample size	300

Research contact person
Name of lead principal investigator	Masato Nagino
Organization	Nagoya University, Graduate School of Medicine
Division name	Divison of Surgical Oncology
Address	65 Tsurumaicho, Showaku, Nagoya, 466-8550, Japan
TEL	052-744-2223
Email

Public contact
Name of contact person	Tomoki Ebata
Organization	Nagoya University, Graduate School of Medicine
Division name	Divison of Surgical Oncology
Address
TEL
Homepage URL
Email	tomoki@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya Surgery Support Organization
Institute
Department

Funding Source
Organization	Nagoya Surgery Support Organization
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2007 Year 09 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 07 Month 20 Day
Anticipated trial start date	2007 Year 09 Month 01 Day
Last follow-up date	2012 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2007 Year 09 Month 06 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000983