UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000051
Receipt number R000000096
Scientific Title A phase I/II study of hepatic arterial 5-flurouracil (5FU) combined with intravenous irinotecan hydrochloride (CPT-11) for metastatic colorectal cancer isolated in the liver. (JCOG 0208-DI)
Date of disclosure of the study information 2005/08/08
Last modified on 2012/09/21 13:25:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A phase I/II study of hepatic arterial 5-flurouracil (5FU) combined with intravenous irinotecan hydrochloride (CPT-11) for metastatic colorectal cancer isolated in the liver. (JCOG 0208-DI)

Acronym

A phase I/II study of hepatic arterial 5FU combined with intravenous CPT-11 for metastatic colorectal cancer isolated in the liver. (JCOG 0208-DI)

Scientific Title

A phase I/II study of hepatic arterial 5-flurouracil (5FU) combined with intravenous irinotecan hydrochloride (CPT-11) for metastatic colorectal cancer isolated in the liver. (JCOG 0208-DI)

Scientific Title:Acronym

A phase I/II study of hepatic arterial 5FU combined with intravenous CPT-11 for metastatic colorectal cancer isolated in the liver. (JCOG 0208-DI)

Region

Japan


Condition

Condition

Metastatic colorectal cancer isolated in the liver

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the dose limiting toxicity (DLT) and the recommended dose (RD) of hepatic arterial 5-flurouracil (5FU) combined with intravenous irinotecan hydrochloride (CPT-11) in patients with metastatic colorectal cancer isolated in the liver, and to evaluate safety and tumor response with this therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Adverse events

Key secondary outcomes

Tumor response, adverse events, tumor response in the liver, induction rate of hepatic arterial chemotherapy


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

Patients undergo implantation of hepatic arterial catheter and port system percutaneously, and then, receive hepatic arterial administration of 5-fluorouracil at day 1,8, and 15 followed by intravenous administration of irinotecan hydrochloride at day 1 and 15. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Unresectable liver metastases from histologically confirmed colorectal cancer.
2) D1 or D2 resection for primary lesion and no extra-hepatic lesions on images.
3) No prior chemotherapy or more than 3 months interval after adjuvant chemotherapy.
4) Measurable lesion according to RECIST.
5) Ages 20 years and above, 70 years or less.
6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
8) Expected survival more than 8 weeks.
9) Written informed consent.

Key exclusion criteria

1) Massive pleural effusion or massive ascites.
2) Active bleeding from digestive organ.
3) Active infection.
4) Watery diarrhea.
5) Other uncontrolled severe illness.
6) Active other malignancy.
7) Prior radiation therapy for abdomen.
8) Positive hepatitis-B antigen or anti-hepatitis-C antibody.
9) Allergy to iodine contrast medium resulting in preclusion of angiography.
10) Severe mental disorder.
11) Pregnant or nursing.
12) Prior placement of hepatic arterial catheter and port system.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Ohtsu

Organization

National Cancer Center Hospital East

Division name

Division of Gastrointestinal Oncology

Zip code


Address

6-5-1 Kashiwanoha, Kashiwa 277-8577, Japan

TEL

04-7133-1111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasuaki Arai

Organization

JCOG0208DI, Coordinating Office

Division name

Division of Diagnostic Radiology, National Cancer Center Hospital

Zip code


Address

5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan

TEL

03-3542-2511

Homepage URL

http://www.jcog.jp/

Email

arai-y3111@mvh.biglobe.ne.jp


Sponsor or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2005 Year 08 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/22922040

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

2003 Year 08 Month 18 Day

Date of IRB


Anticipated trial start date

2003 Year 11 Month 01 Day

Last follow-up date

2007 Year 05 Month 01 Day

Date of closure to data entry

2007 Year 06 Month 01 Day

Date trial data considered complete

2007 Year 06 Month 01 Day

Date analysis concluded

2007 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 08 Day

Last modified on

2012 Year 09 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name