UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II study of gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer
Acronym	gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer
Scientific Title	Phase I/II study of gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer
Scientific Title:Acronym	gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer
Region	Japan

Condition
Condition	Patients with advanced biliary tract cancer that was not amenable to potentially curative surgery or that had recurred after surgery
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the safety of GCS therapy for phase I and efficacy of GCS therapy for phase II.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I Safety Phase II Overall Survival
Key secondary outcomes	Phase II Toxicity and response rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeasted every 2 weeks.
Interventions/Control_2
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. Patients who has undergone adjuvant chemotherapy are eligible if at least 6 months has passed since the last administration. 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 >=60 mL/min) 6.No other serious comorbid disease 7.Adequate oral intake 8.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 who are pregnant or lactating, or have an intention to get pregnant 5. Patients with a history of severe drug allergy 6. Patients with other serious comorbid disease 7. Patients with mental disease 8. Patients who are judged inappropriate for the entry into the study by the principle doctor 9. Patients with watery diarrhea
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Middle name Last name Etsuro Hatano
Organization	Kyoto University Hospital
Division name	Department of Surgery, Graduate School of Medicine
Zip code
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-4349
Email	etsu@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	2010 Year 11 Month 14 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	Main results already published
Date of protocol fixation	2010 Year 10 Month 18 Day
Date of IRB	2010 Year 10 Month 18 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2013 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 10 Month 28 Day
Last modified on	2020 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005338