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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000051
Receipt No. 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

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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
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

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
URL(English) https://upload.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


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