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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007244
Receipt No. R000008538
Scientific Title A randomized phase II study of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy for resected biliary tract cancer
Date of disclosure of the study information 2012/02/10
Last modified on 2015/02/12

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Basic information
Public title A randomized phase II study of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy for resected biliary tract cancer
Acronym A randomized phase II study of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy for resected biliary tract cancer
Scientific Title A randomized phase II study of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy for resected biliary tract cancer
Scientific Title:Acronym A randomized phase II study of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy for resected biliary tract cancer
Region
Japan

Condition
Condition Biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy in patients with resected biliary tract cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease Free Survival
Key secondary outcomes Overall Survival
Safety
Completion rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GEM : day 1, 8, 15 1000mg/m2 IV
q4 weeks
12 cycles
Interventions/Control_2 GEM : day 8, 15 1000mg/m2 IV
TS-1 : day 1-14 60mg/m2 PO
q3 weeks
16 cycles
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Biliary tract cancer. Histologically or cytologically confirmed adenocarcinoma, adenosquamous carcinoma. Surgical resection (Cur B/C, Nodal status (+))
(2) No previous chemotherapy against biliary tract cancer.
(3) No previous radiotherapy against biliary tract cancer.
(4) EOCG performance status of 0-2
(5) Age over 20
(6) Have a life expectancy of at least 2 months
(7) Sufficient organ function defined as :
Hb over 9.0g/dl
WBC over 3000/mm3
ANC over 1500/mm3
PLT over 100,000/mm3
AST/ALT under upper limit X 2.5
T-Bil & under upper limit X 3
Creatinine upper limit
(8) Written informed consent
Key exclusion criteria (1) active interstitial pneumonia
(2) unstable pleural effusion
(3) with metastasis
(4) patients with uncured other malignancies
(5) active severe infection
(6) patients with severe complication
(7) patients with uncontrollable angina pectoris or a new onset of myocardial infarction within 3 months
(8) uncontrollable diabetes mellitus, hypertension
(9) psychiatric disorder
(10) women in pregnancy, potential pregnancy, or breast feeding
(11) other inappropriate cases according to primary doctor's evaluation
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Miyazaki
Organization Chiba University Graduate School of Medicine
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana Chuo-ku, Chiba
TEL 043-226-2103
Email masaru@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Kato
Organization Chiba University Graduate School of Medicine
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana Chuo-ku, Chiba
TEL 043-226-2103
Homepage URL
Email akato@faculty.chiba-u.jp

Sponsor
Institute Adjuvant Therapy for BTC Research Group
Institute
Department

Funding Source
Organization Chiba University Graduate School of Medicine, Department of General Surgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 千葉大学病院〔千葉県)、平和病院(神奈川県)、大網病院(千葉県)、小田原市立病院(神奈川県)、上都賀総合病院(栃木県)、匝瑳市民病院(千葉県)、君津中央病院(千葉県)、さいたま赤十字病院(埼玉県)、聖隷横浜病院(神奈川県)、船橋中央病院(千葉県)、浦賀病院(神奈川県)、済生会習志野病院(千葉県)、千葉市立青葉病院(千葉県)、千葉市立海浜病院(千葉県)、多摩総合医療センター(東京都)、千葉医療センター(千葉県)、千葉労災病院(千葉県)、須坂病院(長野県)、成田赤十字病院(千葉県)、深谷赤十字病院(埼玉県)、松戸市立病院(千葉県)、杏雲堂病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 10 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
2008 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2015 Year 07 Month 01 Day
Date trial data considered complete
2015 Year 12 Month 01 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 07 Day
Last modified on
2015 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008538

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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