pseudomyxoma peritonei
Conditions
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient diagnosed as pseudomyxoma peritonei 2) Patient with no distant metastasis to liver, lungs or lymph nodes on CT scans within 3 months before registration 3) Patient who has not received radiation therapy for pseudomyxoma peritonei 4) Patient who has not received chemotherapy for pseudomyxoma peritonei within a month prior to cytoreductive surgery. 5) Patient aged from 20 to 80 years 6) Patient with ECOG performance status of 0 or 1 7) Patient who meets all the following criteria of clinical laboratory parameters based on the results obtained within 14 days before registration; 1. Leucocyte count >= 3000/micro L 2. Neutrophil count >= 1500/micro L 3. Hemoglobin >= 8.0 g/dL 4. Platelet count >= 100000/micro L 5. Total bilirubin <= 2.0 mg/dL 6. AST <= 150 IU/L 7. ALT <= 150 IU/L 8. Estimated creatinine clearance (Ccr) >= 50 mL/min Ccr is calculated using the following Cockkroft-Gault equation. Ccr for male = [(140 - age) x body weight(kg)] / [72 x serum creatinine (mg/dL)] Ccr for female = 0.85 x [(140 - age) x body weight(kg)] / [72 x serum creatinine (mg/dL)] 8) For women of childbearing potential, pregnancy test performed within 7 days before registration must be negative. 9) Patient who signed and submitted an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patient who has a history of multiple cancers within 5 years before registration, with the exception of carcinoma in situ and a disease equivalent of intramucosal carcinoma. 2) Patient who is associated with unstable angina pectoris that occurred or worsened within 3 weeks before registration, or patient with a history of cardiac infarction that developed within 6 months before registration. 3) Patient with serious diseases including uncontrolled congestive cardiac failure and abnormal cardiac rhythm. 4) Patient who is associated with or has a history of either fibroid lung or interstitial pneumonia or both. Patient with imaging findings suggestive of the diseases. 5) Patient who is pregnant or breast feeding, or who refuses to use appropriate birth control. 6) Patient whose consent is suspicious in terms of his/her mental and legal state. 7) Patient who is considered by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival, recurrence-free survival and frequency and grade of adverse events | — |
Countries
Japan
Contacts
Public ContactKyoko Furuta
National Center for Global Health and Medicine Department of Surgery
Outcome results
None listed