UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Adjuvant chemotherapy using gemcitabine+ CDDPin patients with resected biliary cancer, phase II study
Title of the study (Brief title)	Adjuvant chemotherapy using gemcitabine+ CDDP
Region	Japan Asia(except Japan) North America

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

Objectives
Narrative objectives1	Safety and efficacy of cisplatin + Gemcitabine chemotherapy as adjuvant chemotherapy for resected bile duct cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	disease free survival
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	GEM+CDDP study
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Bile duct cancer, pathological diagnosis as adenocarcinoma including adenoaquamous cell carcinoma, Stage is I-IV and R 0-1 resection. 2)Patients never had chemo-radiation therapy. 3) registration within 10 week after operation. 4)PS is 0-1 5)Good oral intake 6)no ascites and distance metastasis 7)clear of age limited 8)pass the criteria as below Hb 3000/mm3, WBC 3000/mm3, Plt 10,000/mm3 AST,ALT 150IU/L, T-Bli 3.0mg.dl, Cr 1.2mg/dl, 9) get informed consent
Key exclusion criteria	1)Recurrence before registration 2)evidence of ascites and pleural effusion. 3)Evidence of cardiac effusion 4)Patients have pneumonia or pleural fibrosis. 5)Uncontrolled diarrhea 6)No evidence of OMI 3 months before registration. 7) No viral hepatitis 8)Uncontrolled DM 9)No BTF 2 week before registration. 10)There are not complication, such as cardiac, renal failure and/or liver failure, peptic ulcer, bowel pararitic disorder and stable for mental status. 11)no allergy. 12)No evidence of other organ malignancy.
Target sample size	28

Research contact person
Name of lead principal investigator	Keiichi Kubota
Organization	Dokkyo Medical Uniiversity
Division name	Second department of Surgey
Address	880 Kitakobayashi, Mibu, Tochigi, Japan
TEL	0282-87-2158
Email	shimodamtisugi@hotmail.com

Public contact
Name of contact person	Mitsugi Shimoda
Organization	Dokkyo Medical Uniiversity
Division name	Second department of Surgey
Address	880 Kitakobayashi, Mibu, Tochigi, Japan
TEL	0282-87-2158
Homepage URL
Email	shimodamitsugi@hotmail.com

Sponsor
Institute	Dokkyo Medical Uniiversity
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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 04 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 04 Month 15 Day
Last modified on	2016 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012279