Unique ID issued by UMIN | UMIN000011384 |
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Receipt number | R000013124 |
Scientific Title | A prospective study to investigate the efficacy of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for pseudomyxoma peritonei |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2021/02/17 19:49:14 |
A prospective study to investigate the efficacy of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for pseudomyxoma peritonei
PMP study
A prospective study to investigate the efficacy of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for pseudomyxoma peritonei
PMP study
Japan |
pseudomyxoma peritonei
Gastroenterology | Hematology and clinical oncology | Surgery in general |
Gastrointestinal surgery | Obstetrics and Gynecology |
Malignancy
NO
To investigate the efficacy and safety of perioperative intraperitoneal chemotherapy (PIC) combined with cytoreductive surgery in patients with pseudomyxoma peritonei. PIC consists of hyperthermic intraperitoneal chemotherapy performed during surgery and early postoperative intraperitoneal chemotherapy.
Safety,Efficacy
Phase I,II
Overall survival (5 years)
Disease-free survival, recurrence-free survival and frequency and grade of adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
Cytoreductive surgery (CRS), Hyperthermic intraperitoneal chemotherapy (HIPEC), Early postoperative intraperitoneal chemotherapy (EPIC)
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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.
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.
75
1st name | Yoshimasa |
Middle name | |
Last name | Gohda |
National Center for Global Health and Medicine
Department of Surgery
162-8655
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
03-3202-7181
ygohda@hosp.ncgm.go.jp
1st name | Kyoko |
Middle name | |
Last name | Furuta |
National Center for Global Health and Medicine
Department of Surgery
162-8655
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
03-3202-7181
kfuruta@hosp.ncgm.go.jp
National Center for Global Health and Medicine
National Center for Global Health and Medicine
Japanese Governmental office
National Center for Global Health and Medicine
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
03-3202-7181
rinrijm@hosp.ncgm.go.jp
NO
2013 | Year | 10 | Month | 01 | Day |
Unpublished
75
No longer recruiting
2013 | Year | 06 | Month | 20 | Day |
2014 | Year | 09 | Month | 22 | Day |
2014 | Year | 11 | Month | 01 | Day |
2023 | Year | 09 | Month | 30 | Day |
2024 | Year | 03 | Month | 31 | Day |
2024 | Year | 03 | Month | 31 | Day |
2025 | Year | 08 | Month | 31 | Day |
2013 | Year | 08 | Month | 06 | Day |
2021 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013124
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