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

This study is currently recruiting participants.
Verified March 2009 by Fudan University
Sponsor:
Collaborators:
No 2 hospital affliated to zhejiang medical university
Ruijin Hospital
Shanghai 9th People's Hospital
No 1 hospital affliated to zhejiang medical university
Jiangyin People's Hospital
Liaoning Tumor Hospital & Institute
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00643877
First received: March 24, 2008
Last updated: March 24, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Colorectal Neoplasms
 Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR
Procedure: surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 5 years disease-free survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 5 years overall survival and liver metastasis-free survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No 2 hospital affliated to zhejiang medical university
Ruijin Hospital
Shanghai 9th People's Hospital
No 1 hospital affliated to zhejiang medical 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

No publications provided

Responsible Party: Xujianmin, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00643877     History of Changes
Other Study ID Numbers: 2008－46
Study First Received: March 24, 2008
Last Updated: March 24, 2009
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Colorectal Neoplasms
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
Floxuridine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013