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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001685
Receipt No. R000002014
Scientific Title Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805)
Date of disclosure of the study information 2009/02/04
Last modified on 2014/04/30

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Basic information
Public title Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805)
Acronym Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805)
Scientific Title Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805)
Scientific Title:Acronym Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805)
Region
Japan

Condition
Condition biliary tract neoplasm
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate safety and efficacy of a gemicitabin plus S-1and S-1 alone as a first-line treatment for advanced biliary tract cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall survival (1-year survival)
Key secondary outcomes progression-free survival, response rate, adverse events, severe adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
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 A: Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S-1(60-100 mg/day, day1-14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
Interventions/Control_2 B: Patients receive S-1 alone (80-120 mg/day, day1-28 every 6 weeks). It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
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 biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer
2) Recurrent or unrespectable biliary tract cancer
3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma
4) Without CNS metastasis
5) Without moderate or more ascites/pleural effusion
6) No previous therapy against biliary tract cancer
7) No previous chemotherapy or radiotherapy against any other malignancies
8) ECOG PS of 0 or 1
9) Sufficient oral intake
10) Aged 20 to 79 years old
11) Adequate organ functions
12) 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 or fibroid lung
6) Watery diarrhea
7) Active bacterial or fungous infection
8) Severe complication
9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
10) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuji Okusaka
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
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chigusa Morizane
Organization JCOG0805 Coordinating Office
Division name Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour 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 札幌厚生病院(北海道)
栃木県立がんセンター(栃木県)
自治医科大学(栃木県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がんセンター中央病院(東京都)
杏林大学医学部(東京都)
癌研究会有明病院(東京都)
神奈川県立がんセンター(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23763511
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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 Main results already published
Date of protocol fixation
2008 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2011 Year 04 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
2009 Year 02 Month 04 Day
Last modified on
2014 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002014

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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