UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study to investigate the efficacy of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for pseudomyxoma peritonei
Acronym	PMP study
Scientific Title	A prospective study to investigate the efficacy of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for pseudomyxoma peritonei
Scientific Title:Acronym	PMP study
Region	Japan

Condition
Condition	pseudomyxoma peritonei
Classification by specialty	Gastroenterology Hematology and clinical oncology Surgery in general Gastrointestinal surgery Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Overall survival (5 years)
Key secondary outcomes	Disease-free survival, recurrence-free survival and frequency and grade of adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Cytoreductive surgery (CRS), Hyperthermic intraperitoneal chemotherapy (HIPEC), Early postoperative intraperitoneal chemotherapy (EPIC)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key 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.
Key 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.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Yoshimasa Middle name Last name Gohda
Organization	National Center for Global Health and Medicine
Division name	Department of Surgery
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Email	ygohda@hosp.ncgm.go.jp

Public contact
Name of contact person	1st name Kyoko Middle name Last name Furuta
Organization	National Center for Global Health and Medicine
Division name	Department of Surgery
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Homepage URL
Email	kfuruta@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Global Health and Medicine
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
Tel	03-3202-7181
Email	rinrijm@hosp.ncgm.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	75
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 06 Month 20 Day
Date of IRB	2014 Year 09 Month 22 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2023 Year 09 Month 30 Day
Date of closure to data entry	2024 Year 03 Month 31 Day
Date trial data considered complete	2024 Year 03 Month 31 Day
Date analysis concluded	2025 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 08 Month 06 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013124