UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Phase II trial of TS-1 based thrapy vs TS-1 based therapy + LNT for advanced or Recurrent Gastric Cancer
Title of the study (Brief title)	TS-1 based thrapy vs TS-1 based therapy + LNT (Randomized Phase II trial)
Region	Japan

Condition
Condition	Inoperable or Recurrent Gastric Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and Safety of TS-1 based therapy and TS-1 based therapy + LNT for inoperable and recurrent gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary Endpoint : Time to Treatment Failure(TTF) Secondary Endpoint : Overall Survival(OS), Progression Free Survival(PFS), Quality of Life(QOL), Response Rate(RR), Safety, Compliance
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TS-1 based therapy
Interventions/Control_2	TS-1 based therapy + LNT
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) Histologically proven advaneced or recurrent gastric cancer gastric adenocarcinoma. 2) No previous treatment other than chemotherapy or surgery. 3) ECOG Performance Status 0-2 4) Age > 20 years old 5) Life expectancy over 3 months 6) Adequate organ function for enrollment before 14 days. 7) Measurable lesions according to RECIST guidelines. 8)Sufficient oral in 9) Written informed consent.
Key exclusion criteria	1) Drug hypersensitivity or severe drug allergy. 2) With infectious disease which needs treatment. 3) Uncontrolled medical conditions (e.g., congestive heart failure, ileus, interstitial pneumonia, pulmonary fibrosis, diabetes, interstitial pneumonia, pulmonary fibrosis, renal failure). 4) Patients with severe dysfunction of bone marrow 5) Patients with severe dysfunction of liver 6) Patients who need flucitosine 7) With uncontrolled pleural effusion or ascites. 8) Patients with any symptoms due to metastases to the central nervous system 9) Active concomitant malignancy. 10) Pregnant or lactating women 11) men with intent to bear baby 12) Any other patient whom the physician in charge of the study judges to be not eligible
Target sample size	90

Research contact person
Name of lead principal investigator	Hideki Odan
Organization	Hiroshima University Hospital
Division name	gastrointestinal surgery
Address	1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL	0822575222
Email	hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person	Kazuaki Tanabe
Organization	Hiroshima University Hospital
Division name	gastrointestinal surgery
Address	1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL	0822575222
Homepage URL
Email	ktanabe2@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	Deputy Director of Cancer Treatment Center Department of Medical Oncology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 03 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 02 Month 09 Day
Anticipated trial start date	2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 02 Month 09 Day
Last modified on	2018 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003828