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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000677
Receipt No. R000000814
Scientific Title Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Date of disclosure of the study information 2007/04/19
Last modified on 2014/10/16

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Basic information
Public title Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Acronym Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Scientific Title Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Scientific Title:Acronym Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Region
Japan

Condition
Condition progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the effectiveness and feasibility among CPT-11, TXL or combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/platinum compounds(CDDP or OHP) chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival time.
Key secondary outcomes To determine the qualitative and quantitative toxicity and reversibility of toxicity of each chemotherapeutic regimen.
To estimate antitumor activity.
To estimate the progression free survival time.

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
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A:CPT-11(150mg/m2/day,day1) every 2 weeks
Interventions/Control_2 B:TXL (80mg/m2, day1,8,15) every 4 weeks
Interventions/Control_3 C:TS-1 (80-120mg/day, day1-21), CPT-11(80mg/m2/day, day1,15) every 5 weeks.
Interventions/Control_4 D:TS-1 (80-120mg/day, day1pm~day15am), TXL( 50mg/m2/day, day1,8) every 3 weeks.
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) Patients who have not received prior antitumor chemotherapies without S-1 or S-1/CDDP treatment, immunotherapy, or radiotherapy (including local irradiation for pain control) as primary chemotherapy.
2) Patients who had received resistant for prior antitumor chemotherapy with S-1 or S-1/CDDP treatment as primary chemotherapy in whom either (a) or (b) below are diagnosed to be present by the principal investigator of the trial.
(a) Advanced gastric cancer in which a new lesion or progression has been observed by diagnostic imaging after TS-1 monotherapy or TS-1/CDDP combination chemotherapy (either therapy for 4weeks or more) as primary chemotherapy for gastric cancer.
(b) Recurrence during postoperative chemotherapy by TS-1 monotherapy or within 26 weeks of its completion.
3) Patients in whom at least 2 weeks has passed since the completion of the previous chemotherapy.
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1, 2 or less.
5) A predicted life expectancy of at least 3 months.
6) Preservation of major organ function to satisfy the following : leukocyte count of >=4,000 to <12,000 mm3 ; platelet count of >= 100,000/mm3 ; hemoglobin of >=8.0 g/dl ; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels of <=100 IU/l *Except that even if the AST or ALT value does not fulfill this criterion, if the value is diagnosed to be attributable to the primary disease, such as liver metastasis, the criterion will be no more than 150 IU/l. ; alkaline phosphatase of <=x2 the upper limit of the normal range (ULN) ; serum bilirubin level of <=1.5 mg/dl ; serum creatinine of <=1.2 mg/dl or creatinine clearance level of >=50ml/min (When available, the actual measurement will be used as the eligibility criterion, but the value obtained by using the Cockcroft-Gault formula can also be used)
7) Written informed consent to participate in this study
Key exclusion criteria 1) Have a double cancer patient
2) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
3) Infectious disease
4) Diarrhea (watery stools)
5) Ascites or pleural effusion
6) History of serious drug hypersensitivity (especially such as cyclosporine preparations, containing polyoxyethylene castor oil [Cremophor EL], or such as [vitamin preparations for injection] containing hydrogenated castor oil.
7) Undergoing treatment with other fluoropyrimidine anticancer agents, fluorocytosine, or atazanavir sulfate.
8) Found to have fresh gastrointestinal bleeding that requires repeated transfusion.
9) With liver cirrhosis or jaundice.
10) Undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment.
11) having heart disease, such as ischemic heart disease or an arrhythmia, severe enough to require treatment.
12) With diabetes that is difficult to control.
13) With central nervous system metastasis
14) Pregnant, breast-feeding, or who wish to undergo artificial insemination
15) Any other patient whom the physician in charge of the study judges to be unsuitable
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Imamura Hiroshi
Organization Sakai City Hospital
Division name Department of surgery
Zip code
Address 1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL 072-221-1700
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Furukawa
Organization Kinki University Faculty of Medicen
Division name Department of surgery
Zip code
Address 377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL 072-366-0221
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 19 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
2007 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 24 Day
Last follow-up date
2014 Year 03 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 04 Month 12 Day
Last modified on
2014 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000814

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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