Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

NCT ID: NCT00874406

Last Updated: 2009-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.

Detailed Description

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We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.

Group Type EXPERIMENTAL

tac + folfox4

Intervention Type DRUG

tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later: operation within 28 days after operation: folfox4

2

Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.

Group Type ACTIVE_COMPARATOR

folfox4

Intervention Type DRUG

folfox4 will be done within 28 days after liver resection

Interventions

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tac + folfox4

tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later: operation within 28 days after operation: folfox4

Intervention Type DRUG

folfox4

folfox4 will be done within 28 days after liver resection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age \<= 75 years
* resectable liver metastasis
* remnant liver volume \>= 70%
* without other organ metastasis or peritoneum metastasis
* without contradiction of cardiac and pulmonary diseases

Exclusion Criteria

* age \> 75 years
* unresectable liver metastasis
* remnant liver volume \< 50%
* with other organ metastasis or peritoneum metastasis
* with contradiction of cardiac and pulmonary diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhongshan hospital, Fudan University

Principal Investigators

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jianmin xu, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

department of general surgery, zhongshan hospital, fudan university

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jianmin xu, MD, PHD

Role: CONTACT

008613501984869

Facility Contacts

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jianmin xu, MD, PHD

Role: primary

008613501984869

Other Identifiers

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2009-04

Identifier Type: -

Identifier Source: org_study_id

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