UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006548
Receipt number R000007758
Scientific Title PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer
Date of disclosure of the study information 2011/10/17
Last modified on 2016/04/17 15:40:17

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Basic information

Public title

PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer

Acronym

PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer

Scientific Title

PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer

Scientific Title:Acronym

PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer

Region

Japan


Condition

Condition

advanced biliary tract cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to determine the dose for a phase 2 study, the DLTs, and the MTD.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Safety

Key secondary outcomes

response rate, progression-free survival, overall survival


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: 1000 mg/m2 (day 1,8)
CDDP: 25 mg/m2 (day 1,8)
S-1: dose escalation (day1-14)
Every 3 weeks

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Diagnosed as advanced biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma and ampullary carcinoma
2) No previous therapy against biliary tract cancer
3) ECOG PS of 0 or 1
4) Aged 20 to 80 years old
5) Sufficient oral intake
6) Adequate organ functions
7) Written informed consent

Key exclusion criteria

1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant
3) Psychosis
4) Patients requiring systemic steroids medication
5) Interstitial pneumonia
6) Active bacterial or fungous infection
7) Severe complication
8) Patients who cannot receive neither iodic drug nor gadolinium because of drug allergy
9) Inadequate physical condition, as diagnosed by primary physician

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chigusa Morizane

Organization

National Cancer Center Hospital

Division name

Hepatobiliary and Pancreatic Oncology Division

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

TEL

03-3542-2511

Email

cmorizan@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirokazu Shoji

Organization

National Cancer Center Hospital

Division name

Hepatobiliary and Pancreatic Oncology Division

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

TEL

03-3542-2511

Homepage URL


Email

hshouji@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

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

2011 Year 10 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/26685318

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

2011 Year 08 Month 28 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 10 Month 16 Day

Last modified on

2016 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007758


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name