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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000075
Receipt No. 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

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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
Email

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/
Email jfmc-dc@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000075

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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