UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer
Title of the study (Brief title)	Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer
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 neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety
Key secondary outcomes	Overall response rate, 1-year overall survival rate, rate of response in PCI score

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
Interventions/Control_1	Intravenous chemotherapy (IV) is given on days 1 and 15 and PTX is given intraperitoneally (IP) at 20 mg/m2 on days 1, 8 and 15. This regimen is repeated every 4 weeks.
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 colorectal or appendiceal cancer; peritoneal metastasis; age between 20 and 80 years; Synchronous or metachronous metastasis; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >75,000/mm3); adequate liver function (total serum bilirubin <2.0 mg/dl, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); and an expected survival period of more than 3 months.
Key exclusion criteria	Metastasis to distant organ sites (such as liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions.
Target sample size	20

Research contact person
Name of lead principal investigator	Hideaki Yano
Organization	National Center for Global Health and Medicine
Division name	Department of Surgery
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Email	yano-tky@umin.ac.jp

Public contact
Name of contact person	Yoshimasa Gohda
Organization	National Center for Global Health and Medicine
Division name	Department of Surgery
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Homepage URL
Email	yoshi-gouda@hotmail.co.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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 12 Day
Anticipated trial start date	2013 Year 09 Month 12 Day
Last follow-up date	2016 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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 03 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024136