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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00643877
Recruitment Status : Unknown
Verified March 2009 by Fudan University.
Recruitment status was:  Recruiting
First Posted : March 26, 2008
Last Update Posted : March 25, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR Procedure: surgery Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : December 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 5 years disease-free survival [ Time Frame: 5 years after operation ]

Secondary Outcome Measures :
  1. 5 years overall survival and liver metastasis-free survival [ Time Frame: 5 years after operation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643877


Contacts
Contact: jianmin xu, MD 008613501984869 xujmin@yahoo.com.cn

Locations
China
Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Principal Investigator: jianmin xu, MD         
Sponsors and Collaborators
Fudan University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Ruijin Hospital
Shanghai 9th People's Hospital
First Affiliated Hospital of Zhejiang University
Jiangyin People's Hospital
Liaoning Tumor Hospital & Institute
Investigators
Study Chair: jianmin xu, MD department of general surgery, zhongshan hospital, fudan university
More Information

Responsible Party: Xujianmin, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00643877     History of Changes
Other Study ID Numbers: 2008-46
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Fudan University:
Colorectal Neoplasms
Regional
Liver
Neoplasm Metastasis

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Oxaliplatin
Antineoplastic Agents