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


N/A
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer, Liver Tumor

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Xu Jianmin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Zhongshan hospital

Authority:

United States: Food and Drug Administration

Study ID:

ZSTCC

NCT ID:

NCT01677728

Start Date:

January 2007

Completion Date:

December 2014

Related Keywords:

  • Colorectal Cancer
  • Liver Tumor
  • colorectal liver metastases
  • chemotherapy
  • cetuximab
  • bevacizumab
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis

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