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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004440
Receipt No. R000005298
Scientific Title A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Date of disclosure of the study information 2010/11/01
Last modified on 2018/10/30

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Basic information
Public title A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Acronym A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Scientific Title A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Scientific Title:Acronym A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The durability and feasibility of 6 months continuous DTX+TS-1 administration after R0 gastrectomy is detected in the patients with Stage lllA/lllB gastric ccancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes six months durability rate of TS-1 administration
Key secondary outcomes Overall survival,
Deasease-free survival,
Advers events,
Twelve months durability of TS-1 administration

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 DTX and TS-1 are administrated 45 days after R0 operation.
One course includes
Docetaxel 40mg/m2 on day 1 + TS-1 80mg/m2 between day 1 and day 14, and 7 days rest.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)gastric cancer proven histologically
2)Patients who underwent D2 lymph node dissection to be curative operation
3)gastric cancer in Stage lllA or lllB by the japanese Classification pf Gastric Carcinoma(The 13th Edition)
4)patients older than 20 y.o. and younger than 80 y.o.
5)PS(ECOG)=0-1
6)without any treatment before(radiation therapy, Chemotherapy and/or hormone therapy)
7)patients who can take mesicine orally
8)without any severe complications and limited in the following date
WBC : 3,000/mm3<= and >=12,000/mm3
Neutrophile : 2,000/mm3
Hemoglobin : 9.0g/dl<=
Platelet : 100,000/mm3
T.bil. : 1.5mg/dl>=
AST,ALT : 100IU/L>=
creatinine : 1.2mg/dl
9)with written Informed Consent
Key exclusion criteria 1)Patients with double cancers (simultaneous or different time)
Following cases are eligeble :
1.carcinoma in situ of cervical cancer and/or focal colon cancer in adenoma
2.small multiple cancers whose stages are lower than main cancer
3.double early cancers removed by EMR/EDS
2)patients who has contraindication to TS-1
3)patients who need Flucitosine,Fenitoin and/or Walfarin
4)patients who have a history of severe allergy against medicine in grade 3 or 4
5)patients who have a history of severe allergy against medicine including polysolvate 80
6)with interstitial pneumonia
7)with severe diseases(intestinal paralysis, ileus, uncontrollable DM, Cardiac failure, liver dysfunction)
8)with watery diarrhea
9)Females who are pregnent,nursing or possibility of pregnancy, or have a plan to have baby in future
10)Males who have a plan to have their own baby
11)with HIV (positive) or liver cirrhosis/active hepatitis
12)Edema which needs treatment
13)patients whom doctor in chief decides not to register to this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujitani Kazumasa
Organization Osaka General Medical Center
Division name surgery
Zip code
Address 3-1-56, Bandaihigashi, Suniyosi-ku, Osaka-City
TEL 06-6692-1201
Email fujitani@gh.opho.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 Support 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 NTT西日本大阪病院(大阪府)、八尾市立病院(大阪府)、市立堺病院(大阪府)、大阪医療センター(大阪府)、市立豊中病院(大阪府)、箕面市立病院(大阪府)、関西労災病院(兵庫県)、北野病院(大阪府)、西宮市立中央病院(兵庫県)、大阪府立急性期総合医療センター(大阪府)、大阪北逓信病院(大阪府)、阪南中央病院(大阪府)、土庫病院(奈良県)、市立貝塚病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 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
2010 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 14 Day
Last follow-up date
2017 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 03 Month 19 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 25 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005298

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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