UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001595
Receipt number R000001908
Scientific Title Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer
Date of disclosure of the study information 2008/12/22
Last modified on 2019/04/08 13:00:45

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Basic information

Public title

Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer

Acronym

Randomized phase II study comparing GEM versus TS-1 for advanced bile duct cancer

Scientific Title

Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer

Scientific Title:Acronym

Randomized phase II study comparing GEM versus TS-1 for advanced bile duct cancer

Region

Japan


Condition

Condition

Advanced bile duct cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical effectiveness of TS-1 comparing Gemcitabine for advanced bile duct cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Overall survival(OS)

Key secondary outcomes

Progression free survival(PFS)
Adverse events
QOL
Response rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A:Gemcitabine 1,000mg/m2 is administered with 30-min intravenous infusion on day 1, 8, and 15 every 4 weeks.

Interventions/Control_2

Group B:TS-1 80mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1.Patients with non-resectable bile duct cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer) or recurrent bile duct cancer
2.Histologically or cytologically confirmed adenocarcinoma,squamous cell carcinoma or adeosquamous carcinoma of the bile duct cancer(extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer).
Histologically or cytologically confirmed adenocarcinoma of the intrahepatic bile duct cancer.
3.Patients without the prior treatment except surgery and biliary drainage
4.Patients who received adjuvant chemotherapy 6 months or more ago can be registered.
5.Performance Status:0-1(ECOG)
6.Oral intake is possible.
7.Patients of age =>20 and 80>
8.Sufficient organ functions
(1)hemoglobin>=10.0g/dl
(2)WBC >=3,000/mm3
(3)neutrophils>=1,500/mm3
(4)platelets>=100,000/mm3
(5)AST(GOT)<=100IU (or <=150IU if biliary drainage were present)
(6)ALT(GPT)<=100IU (or <=150IU if biliary drainage were present)
(7)total bilirubin <=2.0mg/dl,(or <=3.0mg/dl if biliary drainage were present)
(8)serum creatinine <= 1.2mg/dl
(9)creatinine clearance>=60ml/min
9.Written informed consent

Key exclusion criteria

1.lung fibrosis or intestinal pneumonia
2.Watery diarrhea
3.Severe infection
4.Severe complication
(heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
5.Medical history of serious allergy reactions to any drug
6.Massive pleural or abdominal effusion
7.Metastasis to central nervous system
8.Active synchronous or metachronous malignancy other than carcinoma in situ
9.Regular use of frucitocin, fenitoin or warfarin
10.Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
11.Severe mental illness
12.Patients who are judged inappropriate for the entry into the study by the investigater

Target sample size

110


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya Ioka

Organization

Osaka International Cancer Institute

Division name

Department of Hepatobiliary and pancreatic Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6945-1181

Email

ioka_ta@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Ioka

Organization

Osaka International Cancer Institute

Division name

Department of Hepatobiliary and pancreatic Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6945-1181

Homepage URL


Email

ioka_ta@hotmail.com


Sponsor or person

Institute

Osaka International Cancer Institute
Department of Hepatobiliary and pancreatic Oncology

Institute

Department

Personal name



Funding Source

Organization

Osaka foundation for the prevention of cancer and cardiovascular diseases

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2008 Year 12 Month 22 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

Terminated

Date of protocol fixation

2008 Year 06 Month 25 Day

Date of IRB

2008 Year 09 Month 01 Day

Anticipated trial start date

2009 Year 01 Month 01 Day

Last follow-up date

2013 Year 07 Month 01 Day

Date of closure to data entry

2013 Year 07 Month 01 Day

Date trial data considered complete

2014 Year 01 Month 01 Day

Date analysis concluded

2014 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 12 Month 22 Day

Last modified on

2019 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001908


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name