NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000677

Registered date:19/04/2007

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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedprogressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy
Date of first enrollment2007/07/24
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A:CPT-11(150mg/m2/day,day1) every 2 weeks B:TXL (80mg/m2, day1,8,15) every 4 weeks C:TS-1 (80-120mg/day, day1-21), CPT-11(80mg/m2/day, day1,15) every 5 weeks. D:TS-1 (80-120mg/day, day1pm~day15am), TXL( 50mg/m2/day, day1,8) every 3 weeks.

Outcome(s)

Primary OutcomeOverall survival time.
Secondary OutcomeTo 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.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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

Related Information

Contact

public contact
Name Hiroshi Furukawa
Address 377-2, Onohigashi, Osakasayama, Osaka, Japan Japan
Telephone 072-366-0221
E-mail
Affiliation Kinki University Faculty of Medicen Department of surgery
scientific contact
Name Imamura Hiroshi
Address 1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064 Japan
Telephone 072-221-1700
E-mail
Affiliation Sakai City Hospital Department of surgery