UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011384
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

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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 Obstetrics 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 or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013124


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name