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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014371
Receipt No. R000016723
Scientific Title Randomized Phase III trial comparing GEM/CDDP/S-1 with GEM/CDDP for unresectable biliary tract cancer (KHBO1401)
Date of disclosure of the study information 2014/06/25
Last modified on 2020/01/27

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Basic information
Public title Randomized Phase III trial comparing GEM/CDDP/S-1 with GEM/CDDP for unresectable biliary tract cancer (KHBO1401)
Acronym GEM/CDDP/S-1 vs GEM/CDDP for biliary tract cancer (KHBO1401)
Scientific Title Randomized Phase III trial comparing GEM/CDDP/S-1 with GEM/CDDP for unresectable biliary tract cancer (KHBO1401)
Scientific Title:Acronym GEM/CDDP/S-1 vs GEM/CDDP for biliary tract cancer (KHBO1401)
Region
Japan

Condition
Condition unresectable biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the superiority of GEM/CDDP/S-1 over GEM/CDDP for unresectable biliary tract cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GEM/CDDP/S-1 (intervention)
Interventions/Control_2 GEM/CDDP (control)
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. Patients with cytologically or histologically proved biliary tract cancer
2. age >=20 years
3. PS 0-2
4. No prior history of chemotherapy or radiotherapy.
5. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count >=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and renal function (creatinine clearance >=45 mL/min)
6.Adequate oral intake
7.Provided written informed consent
Key exclusion criteria 1. Patients with interstitial pneumonia or pulmonary fibrosis
2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months
3. Patients with severe active infection
4. Patients with moderate or marked pleural effusion or ascites necessitating drainage
5. Patients with a history of severe drug allergy
6. Patients with other serious comorbid disease
7. Patients who are pregnant or lactating, or have an intention to get pregnant
8. Patients with mental disease
9. Patients who are judged inappropriate for the entry into the study by the principle doctor
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MASASHI KANAI
Organization Kyoto University Hospital
Division name Department of Clinical Oncology and Pharmacogenomics
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4349
Email kanai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MASASHI KANAI
Organization Kyoto University Hospital
Division name Department of Clinical Oncology and Pharmacogenomics
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4349
Homepage URL
Email kanai@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kansai Hepatobiliary Oncology Group
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2014 Year 06 Month 24 Day
Date of IRB
2014 Year 06 Month 24 Day
Anticipated trial start date
2014 Year 06 Month 24 Day
Last follow-up date
2019 Year 04 Month 16 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 04 Month 16 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 24 Day
Last modified on
2020 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016723

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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