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

This study is currently recruiting participants.

Verified by Fudan University, March 2009

First Received: March 24, 2008 Last Updated: March 24, 2009 History of Changes

Sponsors and Collaborators:	Fudan University No 2 hospital affliated to zhejiang medical university Ruijin hospital, Jiaotong University Shanghai 9th People hospital, Jiaotong University No 1 hospital affliated to zhejiang medical university Jiangshu people's hospital Cancer hospital of Liaoning province
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00643877

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 III

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

Drug Information available for: Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
B: Experimental 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
A: No Intervention Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.	Procedure: surgery radical surgery only

Arms

Assigned Interventions

B: Experimental

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

A: No Intervention

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, Jiaotong University

Shanghai 9th People hospital, Jiaotong University

No 1 hospital affliated to zhejiang medical university

Jiangshu people's hospital

Cancer hospital of Liaoning province

Investigators

Study Chair:

jianmin xu, MD

department of general surgery, zhongshan hospital, fudan university

More Information

No publications provided

Responsible Party:	Zhongshan hospital, Fudan University ( Xujianmin )
Study ID Numbers:	2008－46, no
Study First Received:	March 24, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00643877 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Fudan University:

Colorectal Neoplasms
Regional
Liver
Neoplasm Metastasis

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Floxuridine
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Mitomycins

Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Mitomycin
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Oxaliplatin

Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009