UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007244 |
|---|---|
| Receipt number | 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 21:05:28 |
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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
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
akato@faculty.chiba-u.jp
Sponsor or person
Institute
Adjuvant Therapy for BTC Research Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008538
