A phase II trial of TS-1 and weelky CDDP combined with hyperthermia as therapy of advanced and relapsed gastric cancer

UMIN ID: UMIN000002823

Registered date:03/12/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced and relapsed gastric cancer
• Date of first enrollment: 2009/09/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): TS-1/weekly CDDP plus hyperthermia

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Safety, Overall survival, Progression-free survival time

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. TS-1 or CDDP is contraindicated drug 2. With active infection or inflammation 3. With severe heart failure 4. Severe complications 5. With large amout of ascites or pleural effusion 6. With bone metastasis 7. With brain metastasis 8. Active gastrointestinal bleeding needing blood infusion 9. With diarrhea 10.Under treatment with antipsychotic tranquilizer 11. With active double cancer 12.Pregnant or nursing women 13.Men who like be pregnant 14.Inappropriate patients for this study judged by the physicians

Related Information

• Primary Sponsor: Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
• Secondary Sponsor: Hyakumanben clinic
• Source(s) of Monetary Support: Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine,Hyakumanben clinic