Suspended

A Randomized, Controlled Trial of Target Therapy Plus Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Adenocarcinoma+15

+ Carcinoma

+ Colonic Diseases

From 18 to 75 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: January 2007
See protocol details

Summary

Principal SponsorXu jianmin
Study ContactXu Jianmin, MDMore contacts
Last updated: September 3, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2007

Actual date on which the first participant was enrolled.

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.

NCT01677728
Principal SponsorXu jianmin
Study ContactXu Jianmin, MDMore contacts
Last updated: September 3, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialRectal DiseasesCarcinoma, HepatocellularColorectal Neoplasms

Criteria

9 inclusion criteria required to participate
Performance status (ECOG) 0~1

age between 18 - 75 years old

agreed by patients

colorectal adenocarcinoma pathologically

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7 exclusion criteria prevent from participating
age below 18 years old or greater than 75 years old

haven't pathological diagnosis of colorectal adenocarcinoma with liver metastase

not agreed by patients

unresectable colorectal cancer or liver metastases

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Zhongshan Hospital, Fudan University

Shanghai, ChinaOpen Zhongshan Hospital, Fudan University in Google Maps
SuspendedOne Study Center