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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002181
Receipt No. R000001829
Scientific Title A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Date of disclosure of the study information 2009/07/10
Last modified on 2014/02/10

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Basic information
Public title A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Acronym A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Scientific Title A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Scientific Title:Acronym A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Region
Japan

Condition
Condition advanced gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A feasibility on completion of four courses of S-1 and CPT-11 after gastric resection is evaluated to make the following phase III study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Patients ratio with 4 course completion
Key secondary outcomes 1.Patients ratio with one year course completion
2.Incidence of adverse events
3.Recurrence Free Survival
4. Overall Survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CPT-11 80mg/m2 is administered by drip infusion on day 1.
TS-1 (BSA<1.25 40mg/body/once,1.25<=BSA<1.5 50mg/body/once,BSA>=1.5 60mg/body/ once) is administered twice a day orally between day 1 and day 21.
It takes 35 days for the one course.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Eligible criteria
1. primary gastric cancer diagnosed pathologically.
2. Final curability is B with D2 or D3 lymph node dissection
3. Stage IIIA(T2-N2,T3-N1 or T4-N0) or Stage IIIB(T3-N2 or T4-N1)
4. without any prior treatment for cancer
5. 4-8 weeks interval between surgical operation and following chemotherapy
6. age : 20-75 year old
7. performance status (ECOG):0-1
8. patients who can eat orally
9. without any severe disorder on the organs and with the data satisfied
the following criteria measured within 2 weeks of registration
1) WBC >=4,000/mm3 and <12,000mm3
2) Neutrocyte >=2,000/mm3
3) Platelet >=100,000/mm3
4) Hg >=8.0g.dl
5) T.bil <=1.5mg/dl
6) GOT, GPT <=100 IU/l
7) sCr <=1.2mg/dl
10. written informed consent
Key exclusion criteria Ineligible criteria
1.A fresh bleeding on the digestive tract
2.Severe allergy against medicines or history of allergy
3.with active double cancer
4.with uncontrollable cavity fluid
5.with some infectious diseases and/or febrile condition
6.with brain metastases
7.with some disorders on ECG
8.with heart diseases such as congestive heart failure, symptomatic coronary dysfunction, uncontrollable arrhythmia, infarction/history of infarction
9.with liver cirrhosis and/or active hepatitis
10.with DM uncontrollable
11.with severe pulmonary diseases such as interstitial pneumonia,Pulmonary fibrosis
12.uncontrollable diarrhea
13.under intestinal paralysis or ileus
14.patients with psychological disorder who seems difficult to undergo treatment
15. under medication of ATAZANABIL
16. under continuous medication of steroids
17. with continuous medication of fluoro-pyrimidine, flusitosine, fenitoin,and/or Warfarin
18. pregnant and/or nursing women or patients who like to have children
19. patient who seems difficult to undergo protocol treatment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujitani Kazumasa
Organization National Hospital Organization Osaka National Hospital
Division name Dpt. surgery
Zip code
Address 2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL 06-6942-1331
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fujitani Kazumasa
Organization National Hospital Organization Osaka National Hospital
Division name Dpt. surgery
Zip code
Address 2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL 06-6942-1331
Homepage URL
Email

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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 10 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
2008 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 25 Day
Last follow-up date
2013 Year 04 Month 30 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 07 Month 10 Day
Last modified on
2014 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001829

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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