Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer (PHRAC)

March 24, 2009 updated by: Fudan University

A Prospective,Multi-Center,Randomized Control Trial of Preoperative Hepatic and Regional Arterial Chemotherapy(PHRAC) Using Oxaliplatin, Fluorodeoxyuridine(FUDR) and Mitomycin C(MMC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer

The purpose of this study is to investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in patients receiving curative colorectal cancer resection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We administered FUDR, MMC and Oxaliplatin as preoperative hepatic and regional arterial chemotherapy (PHRAC) to patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Principal Investigator:
          • jianmin xu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age < 75 years with histologically proven adenocarcinoma of the colon or rectum
  • no severe major organ dysfunction
  • WHO performance status of 0 or 1
  • no prior cancer therapy
  • Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan

Exclusion Criteria:

  • age >= 75
  • severe major organ dysfunction
  • WHO performance status of >1
  • prior cancer therapy
  • Stage I or Stage IV

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
PHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR
PHRAC which included of two parts(common hepatic artery chemotherapy and main tumor supplying artery chemotherapy) was performed 7 days before surgery： common hepatic artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg main tumor supplying artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg
No Intervention: A
Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
Procedure: surgery
radical surgery only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
5 years disease-free survival
Time Frame: 5 years after operation
5 years after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
5 years overall survival and liver metastasis-free survival
Time Frame: 5 years after operation
5 years after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
Ruijin Hospital
First Affiliated Hospital of Zhejiang University
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Liaoning Tumor Hospital & Institute
Jiangyin People's Hospital

Investigators

  • Study Chair: jianmin xu, MD, Department of General Surgery, Zhongshan Hospital, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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