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)

UMIN ID: UMIN000000677

Registered date:19/04/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy
• Date of first enrollment: 2007/07/24
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: Overall survival time.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
• Source(s) of Monetary Support: Osaka Clinical Study Supporting Organization