UMIN-CTR Clinical Trial

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