UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002703 |
|---|---|
| Receipt number | 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 | 2020/04/27 17:04:33 |
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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 | 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
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
k.taku@general-hosp.pref.shizuoka.jp
Sponsor or person
Institute
Pharma Valley Center , Shizuoka Industrial Foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003295
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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