UMIN-CTR Clinical Trial

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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