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Effect of Target Therapy on Patients Undergoing Synchronic Hepatectomy for Colorectal Liver Metastases

NCT ID: NCT01677728

Last Updated: 2012-09-03

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

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2014-12-31

Brief Summary

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The aim of this study is to explore whether target therapy in combination with chemotherapy as treatment could improve survival or tumor response in patients undergoing Synchronic Hepatectomy for Colorectal Liver Metastases.

Detailed Description

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In patients with colorectal cancer (CRC), the liver is the most common site of hematogenous metastases. Approximately half of patients develop hepatic metastases during the course of the disease, and hepatic metastases are responsible for death in at least two thirds of CRC patients.

Over the past decade, due to the introduction of irinotecan-based or oxaliplatin-based combination chemotherapy, the median survival among patients with colorectal liver metastases (CLM) has increased from 6 \~8 months to more than 20 months5.In recent years, target therapy has rapidly gained attention for the treatment of CLM and is under active investigation.

Although numerous publications have reported the efficacy of target therapy in combination treatment for CLM patients, most of these studies focused solely on those patients without undergoing resection of liver metastases. In contrast, little work has concentrated on exploring the effection of target therapy for CLM patients undergoing Synchronic Hepatectomy.

Conditions

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Colorectal Cancer Liver Tumor

Keywords

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colorectal liver metastases chemotherapy cetuximab bevacizumab

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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arm A

patients received chemotherapy alone

No interventions assigned to this group

arm B

patients received target therapy combined with chemotherapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age between 18 - 75 years old
* Performance status (ECOG) 0\~1
* colorectal adenocarcinoma pathologically
* without any chemotherapy or radiotherapy
* liver metastases undergoing radical resection
* colorectal cancer undergoing radical resection
* no other metastases
* suitable for chemotherapy
* agreed by patients

Exclusion Criteria

* age below 18 years old or greater than 75 years old
* haven't pathological diagnosis of colorectal adenocarcinoma with liver metastase
* with any chemotherapy or radiotherapy
* with other metastasis
* unresectable colorectal cancer or liver metastases
* unsuitable for chemotherapy or target therapy
* not agreed by patients
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 collaborator

Xu jianmin

OTHER

Sponsor Role lead

Responsible Party

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Xu jianmin

Zhongshan hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xu Jianmin, MD

Role: STUDY_CHAIR

Shanghai Zhongshan Hospital

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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Xu Jianmin, MD

Role: CONTACT

Phone: +86-13501984869

Email: [email protected]

Facility Contacts

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Jianmin Xu, M.D.,Ph.D.

Role: primary

Other Identifiers

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Xjianmin

Identifier Type: REGISTRY

Identifier Source: secondary_id

ZSTCC

Identifier Type: -

Identifier Source: org_study_id