UMIN-CTR Clinical Trial

Basic information
Public title	Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy of Gastric Cancer (AEOLUS)
Acronym	Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy of Gastric Cancer (AEOLUS)
Scientific Title	Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy of Gastric Cancer (AEOLUS)
Scientific Title:Acronym	Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy of Gastric Cancer (AEOLUS)
Region	Japan

Condition
Condition	Gastric neoplasm
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of alleviating Effect of Lafutidine on Toxicity of S-1
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Completion rate of S-1 treatment according to planned
Key secondary outcomes	1) Toxicity 2) The relative total administration dose of S-1

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1: 40mg/m2 PO bid (morning and evening) for 4 weeks with 2 weeks rest In total of 1 year after surgery
Interventions/Control_2	S-1: 40mg/m2 PO bid (morning and evening) for 4 weeks with 2 weeks rest Lafutidine: 10mg/body PO bid (morning and evening) everyday In total of 1 year after surgery
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histological proven gastric carcinoma 2) D>=2 lymph node dissection and curability A or B 3) Stage II/III (except for T1) 4) Patient with negative peritoneal washing cytology 5) Age 20-80 years 6) No prior treatment without surgery 7) Patient can start administration of S-1 within 8 weeks after surgery. 8) Adequate organ functions defined as indicated below (1)WBC >= 4,000 /mm3 , WBC <= 12,000 /mm3 (2)neutrophil >= 1,500 /mm3 (3)Plt >= 100,000 /mm3 (4) T.Bil <= 1.5 mg/dL (5) AST(GOT) , ALT(GPT) <= 100 IU/L (6) Cr < 1.5 mg/dL (7) Ccr >= 60 mL/min/body 9) Written informed consent
Key exclusion criteria	1) Patient with active double cancer (synchronous double cancer and metachronous double cancer), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 2) Patient with administration contraindication of S-1 and Lafutidine 3) Patient with regular use of H2-blocker, PPI, furucytocin, fenytoin, or warfarin. 4) Patients with the past history of severe allergic reactions. 5) Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 6) Severe watery diarrhea. 7) pregnant or nursing patient or with intent to bear baby 8) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Terashima
Organization	Shizuoka Cancer Center
Division name	Div. of Gastrointestinal Surgery, Shizuoka Cancer Center
Zip code	411-8777
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka.
TEL	055-989-5222
Email	m.terashima@scchr.jp

Public contact
Name of contact person	1st name Keisei Middle name Last name Taku
Organization	Shizuoka General Hospital
Division name	Div. of Medical Oncology, Shizuoka General Hospital
Zip code	420-8527
Address	4-27-1 Kitaando, Aoi-ward, Shizuoka-city ,Shizuoka.
TEL	054-247-6111
Homepage URL	http://www.fuji-pvc.jp/center/aeolus/index.aspx
Email	k.taku@general-hosp.pref.shizuoka.jp

Sponsor
Institute	Pharma Valley Center , Shizuoka Industrial Foundation
Institute
Department

Funding Source
Organization	Pharma Valley Center , Shizuoka Industrial Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shizuoka Cancer Center
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.
Tel	055-989-5222
Email	rinsho_office@scchr.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	2009 Year 11 Month 03 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	Completed
Date of protocol fixation	2009 Year 10 Month 14 Day
Date of IRB	2010 Year 01 Month 12 Day
Anticipated trial start date	2010 Year 02 Month 22 Day
Last follow-up date	2014 Year 01 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	2009 Year 11 Month 02 Day
Last modified on	2020 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003295