UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000075 |
|---|---|
| Receipt number | R000000075 |
| Scientific Title | A Phase III Study of Intra-Arterial Hepatic Chemotherapy with 5-FU (WHF) in Patients with Liver Metastases from Colorectal Carcinoma |
| Date of disclosure of the study information | 2005/08/25 |
| Last modified on | 2012/05/10 18:35:42 |
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Basic information
Public title
A Phase III Study of Intra-Arterial Hepatic Chemotherapy with 5-FU (WHF) in Patients with Liver Metastases from Colorectal Carcinoma
Acronym
A Potential Adjuvant Study of Intra-Arterial Hepatic Chemotherapy with 5-FU in Combination with Systemic Chemotherapy (UFT/oral LV) vs Systemic Chemotherapy alone (JFMC32-0501)
Scientific Title
A Phase III Study of Intra-Arterial Hepatic Chemotherapy with 5-FU (WHF) in Patients with Liver Metastases from Colorectal Carcinoma
Scientific Title:Acronym
A Potential Adjuvant Study of Intra-Arterial Hepatic Chemotherapy with 5-FU in Combination with Systemic Chemotherapy (UFT/oral LV) vs Systemic Chemotherapy alone (JFMC32-0501)
Region
| Japan |
Condition
Condition
Liver excision;liver metastasis cancer of colorectal cancer origin
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to investigate whether hepatic arterial infusion of 5-FU (1000mg/m2, weekly) followed by systemic chemotherapy (oral UFT/LV) is superior to systemic chemotherapy alone in the patients with curatively resected hepato-metastatic colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
survival, recurrence in residual liver, recurrence in extrahepatic lesion, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hepatic arterial infusion of 5-FU 1000mg/m2 once a week for 6 months, followed by UFT 300mg/m2/day and leucovorin 75mg/day until 1 year after surgery
Interventions/Control_2
UFT 300mg/m2/day and leucovorin 75mg/day until 1 year after surgery
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
1) Curatively resected metastatic liver tumors form colorectal cancer
2) The first time hepatic resection
3) Potentially curative resection of hepatic metastases without current evidence of other metastatic disease
4) No evidence of carcinoma on the cut surface of hepatic resection
5) No extrahepatic sites of disease
6) No prior chemotherapy and radiotherapy to the liver
7) If adjuvant chemotherapy after primary colorectal tumor resection was used, at least 3 months since prior chemotherapy
8) Adequate bone marrow, hepatic, renal, cardiac and respiratory functions
(1) WBC >= 3,000/mm3
(2) Platelet >= 100,000/mm3
(3) Hemoglobin >= 9.0g/dL
(4) Total bilirubin <= 1.5mg/dL
(5) AST < 100IU/L
(6) ALT < 100IU/L
(7) Protronbin time >=50%
(8) Serum creatinine <= 1.5mg/dL
(9) BUN <= 25mg/dL
(10) Total protein >= 5.9g/dL
(11) Albumin >= 3.0g/dL
(12) CRP <= 2.1mg/dL
9) Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, or 1
10) Oral intake is possible
11) Written informed consent
Key exclusion criteria
1) active synchronous or metachronous malignancy other than carcinoma in situ
2) serious postoperative complications
3) serious coexisting illness
a; diabetes mellitus, uncontrolled or controlled with insulin
b; uncontrolled hypertension
c; history of myocardial infarction, unstable angina within 6 months prior to the registration
d; liver cirrhosis
e; severe pulmonary dysfunction
4) pregnant or nursing
5) severe mental disorders
6) not suitable for participating in the study for any other reason
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Kusano |
Organization
Showa University, School of Medicine
Division name
Department of Surgery, Division of General & Gastroenterological Surgery
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name
Office
Zip code
Address
TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL
03-5627-7594
Homepage URL
http://www.jfmc.or.jp/
jfmc-dc@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2005 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 24 | Day |
Last modified on
| 2012 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000075
