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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006872
Receipt No. R000008118
Scientific Title A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
Date of disclosure of the study information 2011/12/12
Last modified on 2020/01/22

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Basic information
Public title A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
Acronym A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
Scientific Title A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
Scientific Title:Acronym A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
Region
Japan

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

Objectives
Narrative objectives1 A feasibility of TS-1 plus Elental administration, relative performance of the TS-1 and the nutrition condition are to be studied in this phase II trial.
Basic objectives2 Others
Basic objectives -Others feasibility
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 70% of Relative Performance (RP) of TS-1
Key secondary outcomes 1)Nutrition Indicator : Body Weight, BMI, s-Albumin, s-Protein, s-Cholesterol
2)PR of TS-1 on 8 courses
3)AE of TS-1
4)PR of Elental
5)Ratio of patients who were tolerant to the test dose of Elental

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 Tolerance Test of Elental
1)Patients take Ellental during 14 days after the start of oral intake.
2)A 100Kcal of Elental is administered three times between each meal (total 300Kcal/day) = test dose
3)Results :
Tolerant : Patients who can take over 60% or more of test dose can be registered fot second registration

Treatment Schedule
A total of 300Kcal/day of Elental is administered for 42 days as one course.
Four courses administration is required and additional courses is permitted (maximum 365 days)
One Course :
TS-1 continuous administration for 28 days, after 14 days rest.
Elental continuous administration for 42 days.
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

Not applicable
Gender Male and Female
Key inclusion criteria Eligebility Criteria during hospital stat
1)patients 20 years old or more
2)proven gastric cancer histlogecally
3)Stage II or Stage III confirmed by R0 surgery
4)PS (ECOG) between 0 and 2
5)wityout any prior chemotherapy and/or radiation therapy
6)with good oral intake
7)written informed consent to participate in this study
8)without any postoperative complications

Eligebility criteria after discharge (second registration)
Patients registerd in hospital are rechecked for the second registration
1)Stage II (except patients T1 or T3/N0) or Stage III diagnosed at the surgical operation and/or intra-peritoneal cytological examination
2)Patients who can take 60% or more of the test dose of Elental
3)without any severe diseases and with a good condition of important organs for administration of TS-1
a)WBC >= 2,500/mm3
b)neutrophil >= 1,200/mm3
c)platelet >=75,000/mm3
d)hemoglobin >= 8.0g/L
e)AST/ALT <= 100 IU/L
f)total bilirubin <= 1.5mg/dL
g)Creatinin clearance >= 40ml/min
CC by Cockcroft-Gault method is avilable
Key exclusion criteria Exclusion Criteria duriong hospital stay
1)with active double cancer (*)
*Simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years.
Carcinoma in situ or cancers localized in membranous layer are not included to double cancer.
Cancers removed by EMR/ESD are included.
2)with a history of allergy against TS-1 and/or Elental
3)with active infection diseases
4)with uncontrollable hypertension
5)with uncontrollable DM
6)with severe heart diseases clinically
7)with severe lung diseases (interstitial pneumonitis,pulmonary fibrosis, or pulmonary emphysema)
8)with psychologic diseases and/or psychological symptpms
9)women pregnant and/or nursing or women who like to be pregnant
10)patient registered to the other study whose endpoints are same to This study.
11)patients whom doctor decide not to register to this study
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Imamura
Organization Toyonaka City Hospital
Division name Department of Surgery
Zip code
Address 4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL 06-6843-0101
Email imamurahiroshisakai@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Furukawa
Organization Kinki University School of Medicine
Division name Department of surgery
Zip code
Address 377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL 072-366-0221
Homepage URL
Email hiroshi.furukawa@tokushukai.jp

Sponsor
Institute Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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
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 八尾市立病院(大阪府)、大阪府急性期総合医療センター(大阪府)、東大阪市立総合病院(大阪府)、市立豊中病院(大阪府)、市立堺病院(大阪府)、関西医科大学枚方病院(大阪府)、北野病院(大阪府)、JCHO大阪病院(大阪府)、星ヶ丘厚生年金病院(大阪府)、日生病院(大阪府)、大阪医療センター(大阪府)、市立貝塚病院(大阪府)、大阪警察病院(大阪府)、西宮市立中央病院(兵庫県)、大阪府立成人病センター(大阪府)、神戸大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 12 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 82
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason manuscript in preparation
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
2011 Year 10 Month 31 Day
Date of IRB
2012 Year 01 Month 23 Day
Anticipated trial start date
2012 Year 02 Month 08 Day
Last follow-up date
2015 Year 07 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 01 Month 18 Day

Other
Other related information

Management information
Registered date
2011 Year 12 Month 11 Day
Last modified on
2020 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008118

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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