Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for pseudomyxoma peritonei: a prospective study - PMP study

Gohda Yoshimasa0 个研究点目标入组 75 人开始时间: 2019年3月13日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Gohda Yoshimasa