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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010667
Receipt No. R000012226
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)
Date of disclosure of the study information 2013/05/08
Last modified on 2017/05/09

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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 No longer recruiting
Date of protocol fixation
2013 Year 03 Month 19 Day
Date of IRB
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

Other
Other related information

Management information
Registered date
2013 Year 05 Month 08 Day
Last modified on
2017 Year 05 Month 09 Day


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

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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