UMIN-CTR Clinical Trial

Basic information
Public title	Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer: a feasibility study
Acronym	Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer: a feasibility study
Scientific Title	Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer: a feasibility study
Scientific Title:Acronym	Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer: a feasibility study
Region	Japan

Condition
Condition	Peritoneal metastasis from colorectal or appendiceal cancer
Classification by specialty	Hematology and clinical oncology Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility and safety of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes	1-year overall survival rate

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	Histologically proven colon or appendiceal cancer; peritoneal metastasis; age between 20 and 80 years; Synchronous or metachronous metastasis; Eastern Cooperative Oncology Group performance status 0-1; adequate bone marrow function ; and borderline resectable distant metastasis
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 to 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	10

Research contact person
Name of lead principal investigator	1st name Tomomichi Middle name Last name Kiyomatsu
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	tkiyomatsu@hosp.ncgm.go.jp

Public contact
Name of contact person	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
Homepage URL
Email	ygohda@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Center for Global Helth and Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel	0332027181
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	2016 Year 03 Month 03 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
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	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 03 Month 03 Day
Last modified on	2019 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024138