UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000820
Receipt number R000000983
Scientific Title Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer
Date of disclosure of the study information 2007/09/10
Last modified on 2018/09/18 14:33:12

* 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

Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer

Acronym

Bile Duct Cancer Adjuvant Trial (BCAT)

Scientific Title

Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer

Scientific Title:Acronym

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

1st name
Middle name
Last name Masato Nagino

Organization

Nagoya University, Graduate School of Medicine

Division name

Divison of Surgical Oncology

Zip code


Address

65 Tsurumaicho, Showaku, Nagoya, 466-8550, Japan

TEL

052-744-2223

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tomoki Ebata

Organization

Nagoya University, Graduate School of Medicine

Division name

Divison of Surgical Oncology

Zip code


Address


TEL


Homepage URL


Email

tomoki@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya Surgery Support Organization

Institute

Department

Personal name



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)



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

2007 Year 09 Month 10 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

Completed

Date of protocol fixation

2007 Year 07 Month 20 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000983


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name