UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer (JCOG1113, FUGA-BT)
Acronym	Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine pluscisplatin combination therapy in advanced biliary tract cancer (JCOG1113, FUGA-BT)
Scientific Title	Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer (JCOG1113, FUGA-BT)
Scientific Title:Acronym	Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine pluscisplatin combination therapy in advanced biliary tract cancer (JCOG1113, FUGA-BT)
Region	Japan

Condition
Condition	Unresectable or recurrent bilary tract cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the non-inferiority of GS (gemcitabine/S-1) to GC (gemcitabine/cisplatin) for unrescectable or recurrent bilary tract cancer.If the non-inferiority of GS to GC was confirmed, we also evaluate the superiority of GS over GC.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Progression-free survival, Adverse events, Serious adverse events, Clinically-significant adverse events, Response rate, %Planned dose

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	A: Chemotherapy with gemcitabine (1,000 mg/m2/day, day 1,8) and cisplatin (25 mg/m2/day, day 1,8) repeated every 3 weeks
Interventions/Control_2	B: Chemotherapy with gemcitabine (1,000 mg/m2/day, day 1,8) and S-1 (60 mg-100mg/day, day 1-14) repeated every 3 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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Diagnosed as biliary tract cancer (carcinoma of the intrahepatic bile duct (IHBD), extrahepatic bile duct (EHBD), gallbladder (GB), and ampulla of Vater (AV)) 2) Histologically proven adenocarcinoma or adenosquamous carcinoma for patients with EHBD, GB, or AV carcinomas, or adenocarcinoma for IHBD carcinomas 3) Unresectable or recurrent cancer 4) Aged 20 to 79 years old 5) ECOG performance status of 0 or 1 6) Measurable region is not required 7) No previous treatment except surgery and biliary drinage for biliary tract cancer. 8) No previous chemotherapy or radiotherapy for other malignancies. 9) Absence of central nervous system metastasis 10) Absence of moderate or severe ascites and/or pleural effusion 11) Oral intake is possible 12) Absense of watery diarrehea 13) Grade1or less of peripheral sensory neuropathy, peripheral motor neuropathy and tinnitus 14) Adequate organ functions 15) Written informed consent
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Pregnant or lactating women or women of childbearing potential, Male expecting partner's pregnancy 4) Psychiatric disease 5) Patients requiring systemic steroids medication 6) Interstitial pneumonia, pulmonary fibrosis 7) Serious co-existing illness 8) Unstable angina pectoris within 3 weeks, or with a history of myocardial infarction within 6 months 9) Patients requiring flucytosine, phenytoin or warfarin 10) Impossible to use both iodine and gadolinium due to being allergic to contrast agent
Target sample size	350

Research contact person
Name of lead principal investigator	1st name Middle name Last name Okusaka Takuji
Organization	National Cancer Center, Tokyo
Division name	Hepatobiliary and Pancreatic Medical Oncology
Zip code
Address	5-1-1. Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL	(+81)03-3542-2511
Email	tokusaka@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Chigusa Morizane
Organization	JCOG1113 Coordinating Office
Division name	National Cancer Center, Tokyo Hepatobiliary and Pancreatic Medical Oncology
Zip code
Address	5-1-1. Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL	(+81)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	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
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） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 千葉大学医学部（千葉県） 国立がん研究センター中央病院（東京都） 杏林大学医学部（東京都） 東京女子医科大学（東京都） がん研究会有明病院（東京都） 帝京大学医学部（東京都） 北里大学東病院（神奈川県） 東海大学医学部（神奈川県） 神奈川県立病院機構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） 富山大学附属病院（富山県） 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） 関西医科大学附属枚方病院（大阪府） 神戸大学医学部（兵庫県） 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	2013 Year 05 Month 08 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	Completed
Date of protocol fixation	2013 Year 03 Month 19 Day
Date of IRB	2013 Year 04 Month 18 Day
Anticipated trial start date	2013 Year 05 Month 08 Day
Last follow-up date	2019 Year 09 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 13 Day

Other
Other related information

Management information
Registered date	2013 Year 05 Month 08 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012226