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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002703
Receipt No. R000003295
Scientific Title Alleviating Effect of Lafutidine on Toxicity of S-1: Adjuvant Chemotherapy of Gastric Cancer (AEOLUS)
Date of disclosure of the study information 2009/11/03
Last modified on 2013/01/07

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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
Middle name
Last name Masanori Terashima, MD
Organization Shizuoka Cancer Center
Division name Div. of Gastrointestinal Surgery, Shizuoka Cancer Center
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 Japan
TEL
Email

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

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
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
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 No longer recruiting
Date of protocol fixation
2009 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2014 Year 01 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
2009 Year 11 Month 02 Day
Last modified on
2013 Year 01 Month 07 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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