UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021324
Receipt number R000024136
Scientific Title Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer
Date of disclosure of the study information 2016/03/03
Last modified on 2018/03/29 20:55:56

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Basic information

Public title

Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer

Acronym

Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer

Scientific Title

Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer

Scientific Title:Acronym

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

1st name
Middle name
Last name Hideaki Yano

Organization

National Center for Global Health and Medicine

Division name

Department of Surgery

Zip code


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

1st name
Middle name
Last name Yoshimasa Gohda

Organization

National Center for Global Health and Medicine

Division name

Department of Surgery

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan

TEL

03-3202-7181

Homepage URL


Email

yoshi-gouda@hotmail.co.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



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


Address


Tel


Email



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

2013 Year 09 Month 12 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024136


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name