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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036542
Receipt No. R000041524
Scientific Title Randomized Phase II study regarding treatment cycles of neo-adjuvant chemotherapy with biweekly triplet gemcitabine/cisplatin/s-1 for biliary tract cancer
Date of disclosure of the study information 2019/04/19
Last modified on 2019/06/10

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Basic information
Public title Randomized Phase II study regarding treatment cycles of neo-adjuvant chemotherapy with biweekly triplet gemcitabine/cisplatin/s-1 for biliary tract cancer
Acronym KHBO-1902
Scientific Title Randomized Phase II study regarding treatment cycles of neo-adjuvant chemotherapy with biweekly triplet gemcitabine/cisplatin/s-1 for biliary tract cancer
Scientific Title:Acronym KHBO-1902
Region
Japan

Condition
Condition Resectable Biliary Tract Cancers
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare resection rate in the patients biliary tract cancers who underwent 3 cycles or 6 cycles of neo-adjuvant chemotherapy with biweekly gemcitabine+cicpaltin+S1
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes R0 resection rate
Key secondary outcomes Resection rate, Recurrence-free survival, Overall survival, Anti-tumor effect, Completion rate, Dose intensity, Adverse effect, Rate of LN metastasis

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 3 cycles of neoadjuvant chemothrapy with biweekly gemcitabine, cisplatin, and S-1.
Interventions/Control_2 6 cycles of neoadjuvant chemothrapy with biweekly gemcitabine, cisplatin, and S-1.
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) Resectable biliary tract cancer (BTC)
2) Age >= 20 y/o
3) PS 0 or 1
4) No prior treatment for BTC except for drainage
5) Proper organ function
(1) Neutrophil >= 1500/uL
(2) Platelet >= 100,000/uL
(3) Hb >= 9.0 g/dL
(4) AST and ALT <= 150 U/L
(5) Bilirubin <= 1.5 mg/dL
(6) Creatinin <= 1.2 mg/dL
(7) Creatinin clearance >= 60
6) Oral intake
7) Appropriate for neoadjuvant chemotherapy in each hospital
8) Written informed consent
Key exclusion criteria 1) Distant metastasis
2) Double cancer
3) Interstitial pneumonia
4) Waterly diarrhea
5) Active infection except for hepatitis and cholangitis
6) Several organ dysfunction (Heat failure, Renal failure, Liver failure, GI bleeding, Ileus, Uncontrolled DM)
7) Pregnancy
8) Psychic disorder
9) Allergy
10) Others

Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shogo
Middle name
Last name Kobayashi
Organization Osaka University Hospital
Division name Gastroenterological Surgery
Zip code 565-0871
Address 2-15 Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Email s-kobayashi@umin.ac.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Ioka
Organization KHBO
Division name Osaka International Cancer Institute
Zip code 541-8567
Address 3-1-69 Otemae, Chuo-ku, Osaka City, Osaka
TEL 06-6945-1181
Homepage URL
Email ioka-ta@umin.ac.jp

Sponsor
Institute KHBO
Institute
Department

Funding Source
Organization none
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 IRB of Osaka International Cancer Institute
Address 3-1-69 Otemae, Chuo-ku, Osaka City, Osaka
Tel 06-6945-1181
Email rinri01@opho.jp

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
2019 Year 04 Month 19 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 19 Day
Last modified on
2019 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041524

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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