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


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 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


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

Value
https://center6.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