A Phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable pancreatic cancer.

UMIN ID: UMIN000001221

Registered date:01/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: unresectable pancreatic cancer
• Date of first enrollment: 2008/06/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): One cycle of the chemotherapy regimen consist of a drip infusion of 1000mg/m2 of GEM weekly for 3 weeks and 1 week off, and this was repeated every 4 weeks. Patients receive hyperthermia once per week, each session is scheduled for the day after administratin of GEM, employing radio frequency capacitive heating; Thermotron RF8. The duration of heating session is from 40 minutes to 50 minutes.

Outcome(s)

• Primary Outcome: 1-year survival rate
• Secondary Outcome: safety, performance status, response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclusion criteria in this study are as follows: 1. Interstitial pneumonitis, pulmonary fibrosis with radiological findings 2. Recurrence after resection for CBD cancer or presence of hepatocellular carcinoma, duodenal cancer, peritonitis carcinomatosa. 3. Presence of ileus 4. Presence of active biliary infection 5. Presence of uncontrolled diabetes, severe liver dysfunction, unstable angina, myocardial infarction within three months. 6. Presence of active severe infection 7. Pregnant, lactating women or women with suspected pregnancy. 8. Medical history of severe hypersensitivity. 9. Severe complications 10. 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