A prospective interventional study for pseudomyxoma peritonei

JRCT ID: jRCTs031180254

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pseudomyxoma Peritonei
• Date of first enrollment: 13/03/2019
• Target sample size: 75
• Study type: Interventional

Intervention(s)

CRS was conducted with the intention to remove all tumor bearing peritoneum, if necessary by organ resections according to
Sugarbaker's procedure: Total anterior parietal peritonectomy, omentectomy with or without splenectomy, right and left subphrenic
peritonectomy, pelvic peritonectomy with or without low anterior resection and cholecystectomy, lesser omentectomy with stripping
of the omental bursa. Following CRS, mitomycin C was given at a dose of 10 mg/m2, heated to 42 degrees Celsius, for an hour
using the open coliseum technique. For administration of EPIC, four percutaneous peritoneal catheters were introduced, one in each
abdominal quadrant. The drugs used for EPIC were 5-fluoruracil (5-FU) 15 mg/body on days 1-4. The drugs were diluted in 1000 ml
dextrose and were contained intraperitoneally for 23 h.

Outcome(s)

• Primary Outcome: Overall survival (5 years)
• Secondary Outcome: Disease-free survival recurrence-free survival and frequency grade of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both
• Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Gohda Yoshimasa
• Secondary ID(s): UMIN000011384