UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000638
Receipt No. R000000773
Scientific Title Randomized phase II study of TS-1/CPT-11 versus TS-1/TXL in advanced/recurrent gastric cancer
Date of disclosure of the study information 2007/04/01
Last modified on 2018/07/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized phase II study of TS-1/CPT-11 versus TS-1/TXL in advanced/recurrent gastric cancer
Acronym OGSG0402
Scientific Title Randomized phase II study of TS-1/CPT-11 versus TS-1/TXL in advanced/recurrent gastric cancer
Scientific Title:Acronym OGSG0402
Region
Japan

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

Objectives
Narrative objectives1 A combination of TS-1 plus CPT-11 is compared to that of TS-1 plus CPT-11 in terms of response rate and adverse events for the advanced metastatic gastric cancer as the randomized phase II study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate(RECIS)
Key secondary outcomes 1.Progression free survival (PFS)
2.Overall survival (OS)
3.Adverse Events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A: TS-1(80mg/m2/day, between day 1 and 21) + CPT-11(80mg/m2/day, on day and day 15 ) are administered in every 5 weeks (1 course).
Interventions/Control_2 Group B: TS-1(80mg/m2/day between day 1 and 14) + Taxol(50mg/m2/day, on day 1 and 8 ) are administered in every 3 weeks (1 course).
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 1) Diagnosed gastric cancer, histologically
2)with metastatic lesions which can be measured
3) without any prior radiation therapy or chemotherapy using CPT-11, TXL or TS-1
4) Performance Status 0 &#8211; 2 in ECOG classification
5) age 20<= and =>75
6) sufficient oral intake
7) Survival period is expected over three months.
8) without any sever disorders in any organs
1. bone marrow function
. WBC: 4,000/mm3<= and > 12,000/mm3
. Neutrocyte: 2,000 /mm3<=
. Hb: 8.0 g/dl <=
. Platelet: 100,000/mm3<=

2. Liver function
. Total Bil.: 1.5 mg>=
. GOT, GPT: < 100 IU/l

3 Renal Function
. Creatinin: 1.2 mg/dl>=
. Creatinin Clearance: 50 mg/mm <= (by Cockcroft-Gault)
9) Written Informed Consents
Key exclusion criteria 1) active double cancer
2) with other severe diseases (ileus, interstitial pneumonia/pulmonary fibrosis, cardiac failure, renal dysfunction, liver dysfunction)
3) with infectious diseases
4) under condition of diarrhea
5) with marked chest or abdominal fluid
6) history of allergy against medicine
7) receiving fluoropyrimidine, antifungal flusitosine or Atazanabil sulfate
8) with gastrointestinal bleeding which needs blood transfusion
9) with liver cirrhosis or jaundice
10) with psychiatric disease which needs medicine
11) with cardiac disease which needs therapy
12) with uncontrolled D M
13) with metastasis to the central nerve system
14) under pregnancy or nursing the baby
15) excluded by doctor due to the other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujitani Kazumasa
Organization National Hospital Orgamnzation
Osaka Medical Center
Division name Dpt.Surgery
Zip code
Address 2-1-14.Houenzaka, chuo-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 Orgamnzation
Division name Dpt.Surgery
Zip code
Address 2-1-14.Houenzaka, chuo-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
2007 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://ar.iiarjournals.org/content/34/2/851.long
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
2004 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 01 Day
Last follow-up date
2009 Year 11 Month 01 Day
Date of closure to data entry
2009 Year 11 Month 01 Day
Date trial data considered complete
2009 Year 11 Month 01 Day
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 15 Day
Last modified on
2018 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000773

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.