UMIN-CTR Clinical Trial

Public title

Randomized pahse III study evaluating the efficacy of hepatic arterial infusion chemotherapy for metastatic colorectal cancer patients with unresectable liver metastases

Acronym

JIVROSG-0606(HAIC Phase III)

Scientific Title

Randomized pahse III study evaluating the efficacy of hepatic arterial infusion chemotherapy for metastatic colorectal cancer patients with unresectable liver metastases

Scientific Title:Acronym

JIVROSG-0606(HAIC Phase III)

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Surgery in general	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate safety and efficacy of hepatic arterial infusion chemotherapy using 5FU for advanced metastatic colorectal cancer patients with unresectable liver metastases comparing with the standard treatment of FOLFOX+Bevacizumab

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III

Primary outcomes

Overall survival period

Key secondary outcomes

Adverse events
Time to treatment failure

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine	Device,equipment	Maneuver

Interventions/Control_1

In the tested group, after the radiological placement of port and catheter system, hepatic arterial infusion using 5FU is performed within 6 months at the longest, and then FOLFOX+Bevacizumab therapy is performed.

Interventions/Control_2

In the control group, FOLFOX+Bevacizumab therapy is performed.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)pathologically confirmed colorectal cancer
2)ALP more than 600 IU/L and unresectable liver metastases
3)No prior treatment using L-OHP or Bevacizumab
4)20 years old or more
5)Performance status (ECOG):0-2
6)No mtter of measurable lesion
7)Previous chemotherapy as folloes;
- No prior chemotherapy
- Chemotherapy of fluoropyrimidines for less than 2 weeks
- Previous adjuvant chemotherapy of fluoropyrimidines with more than 6 months interval to the recurrence, and no previous chemotherapy to the recurrence
8)Within normal function of major organs
9)More than 8 weeks survival expected
10)Written informed consent

Key exclusion criteria

1)Massive pleural effusion or ascites
2)Bleeding of digestive organ
3)Uncontrolled active infection
4)Severe complications (ileus, interstitial pneumonia, uncontrolled-diabetis, cardiac failure, renal failure, liver cirrhosis, liver failure-
5)Active other malignancy
6)Phsicological disorder
7)Pregnancy or lactation
8)Positive HBs
9)Severe allergy to iodine contrast medium
10)Bone metastases requiring local treatment
11)Brain metastasis or suspiciou brain metastasis
12)Thrombosis or Embolism within 1 year
13)Grade 2 or more sensory disturbance (CTCAEv3.0)
14)Requiring anti-thrombogenic therapy to prevent thrombosis
15)Unsuitable by physician's decision

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Kei Muro

Organization

Aichi Cancer Center Hospital

Division name

Department of Medical oncology

Zip code

Address

1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan

TEL

052-762-6111

Email

Name of contact person

1st name
Middle name
Last name	Takashi Ura

Organization

Aichi Cancer Center Hospital

Division name

Department of Medical oncology

Zip code

Address

1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan

TEL

052-762-6111

Homepage URL

Email

tura@aichi-cc.jp

Institute

Japan Interventional Radiology in Oncology Study Group (JIVROSG)

Institute

Department

Personal name

Organization

Japanese Society of Implantable Port Assisted Treatment

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2008

Year

08

Month

29

Day

Date of IRB

Anticipated trial start date

2008

Year

11

Month

01

Day

Last follow-up date

2013

Year

11

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

11

Month

10

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=R000001808