UMIN-CTR Clinical Trial

Basic information
Public title	Phase 1 study of Docetaxel and Oxaliplatin and TS-1 for unresectable / recurrent gastric cancer (KOGC-06)
Acronym	KOGC-06
Scientific Title	Phase 1 study of Docetaxel and Oxaliplatin and TS-1 for unresectable / recurrent gastric cancer (KOGC-06)
Scientific Title:Acronym	KOGC-06
Region	Japan

Condition
Condition	unresectable / recurrent gastric cancer
Classification by specialty	Medicine in general Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess maximum tolerated dose in order to determine recommended dose of Docetaxel and Oxaliplatin and TS-1 in patients with unresectable or recurrent gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Incidence of dose limiting toxicity
Key secondary outcomes	Overall 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	Docetaxel and Oxaliplatin and TS-1concurrent therapy : Level 1 Docetaxel : 32 mg/m2 i.v. (day1) Oxaliplatin : 105 mg/m2 i.v. (day1) TS-1 : 80 mg/m2/day p.o. (day1-14) to be repeated every 3 weeks. Docetaxel is administered with an initial dose of 32mg/m2, stepped up to 40mg/m2. Oxaliplatin is administered with an initial dose of 105mg/m2, stepped up to 130mg/m2.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Histological confirmation of gastric cancer. (2) Patients with an unresectable or recurrent gastric cancer. (3) Patients with confirmation of measurable or evaluable lesions within 28 days prior to entry. (4) No prior treatment of Docetaxel or Oxaliplatin or TS-1. (5) No prior treatment of radiation. (6) age: >=20 and <75 when received informed consent. (7) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 -1. (8) Life expectancy estimate 3 months, and more. (9) Vital organ functions (listed below) are preserved within 14 days prior to entry. Neutrophils>=1,500/mm3 Platelets>=100,000/mm3 Hemoglobin>=8.0 g/dl AST and ALT <=100 I/U Total bilirubin<=1.5 mg/dl Serum creatinine <= 1.2 mg/dl Estimated creatinine clearance rate ( Cockcroft-Gault formula) >= 60 mL/min (10) Patients able to oral intake (11) Written informed consent.
Key exclusion criteria	(1) Patients with severe ischemic heart disease or arhythmia. (2) Patients with myocardial infarction within 6 months. (3) Patients with liver cirrhosis or active hepatitis. (4) Patients with dyspnea needing oxygen. (5) Patients with fresh gastrointestinal bleeding which require a repeat blood transfusion. (6) Patient who have been treated with antipsychotic drugs, or patient with mental disorder requiring medication. (7) Patients with uncontrolled diabetes mellitus. (8) Patients with ileus or subilues. (9) Patients with fever infection. (10) Patients who have history of active simultaneous or metachronous double cancers within 5 year. However, patient with carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer. (11) Patients with CNS metastases. (12) Patients with acute infectious diseases. (13) Patients with peripheral neuropathy. (14) Patients with history of severe adverse event suspected to be caused by drugs. (15) Patients with history of severe adverse event suspected to be caused by Polyoxyethylene Castor Oil or hydroxyohlorinatedcasteroil. (16) Patients who are pregnant women, possibly pregnant women, willing to become pregnant, and nursing mothers. (17) Patients who are inappropriate for the study at the physician's assessment.
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Hirofumi Middle name Last name Kawakubo
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Email	hkawakubo@z3.keio.jp

Public contact
Name of contact person	1st name Hirofumi Middle name Last name Kawakubo
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Homepage URL
Email	hkawakubo@z3.keio.jp

Sponsor
Institute	Keio University School of Medicine, Department of Surgery
Institute
Department

Funding Source
Organization	None
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	Keio University School of Medicine, Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.ac.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	2014 Year 11 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	5
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	Terminated
Date of protocol fixation	2014 Year 11 Month 14 Day
Date of IRB	2014 Year 11 Month 12 Day
Anticipated trial start date	2014 Year 11 Month 19 Day
Last follow-up date	2017 Year 11 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 11 Month 19 Day
Last modified on	2019 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018281