JPRN-jRCTs031180254
Completed
Phase 2
Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for pseudomyxoma peritonei: a prospective study - PMP study
Gohda Yoshimasa0 sites75 target enrollmentMarch 13, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gohda Yoshimasa
- Enrollment
- 75
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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) \>\= 50mL/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 bodyweight(kg)] / \[72 x serum creatinine (mg/dL)] 8\) For women of childbearing potential, pregnancytest performed within 7 days before registration must be negative. 9\) Patient who signed and submitted an informed consent form.
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.
Outcomes
Primary Outcomes
Not specified
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