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 |
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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
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/
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
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
