A phase II trial of FOLFIRI combined with hyperthermia as second-line therapy of unresectable colon cancer with liver metastases

UMIN ID: UMIN000001998

Registered date:01/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colon cancer patients with liver metastases who had been treated by FOLFOX as first-line therapy
• Date of first enrollment: 2009/06/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): FOLFIRI plus hyperthermia

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Time to treatment failure, Overall survival, Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Patients who has received blood transfusion, blood products, and medicine made of blood formation factor within seven days of registration. 2.Medical history of severe hypersensitivity. 3.Massive ascites, pleural or pericardial effusin that required drainage. 4.With active infection. 5.With brain metastasis 6.With active double cancer. 7.Presence of uncontrolled hypertension. 8.Presence of uncontrolled diabetes. 9.Presence of unstable angina, myocardial infarction within three months. 10.Active gastrtrointestinal bleeding. 11.With intestinal paralysis, intestinal obstruction. 12.With diarrhea. 13.Patients receiving Atazanabil. 14.Pregnant or nursing women, men or women who like be pregnant. 15.Inappropriate patients for this study judged by the physicians.

Related Information

• Primary Sponsor: Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
• Source(s) of Monetary Support: none