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

Phase 3

• Conditions: Colorectal Neoplasms
• Interventions: Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR; Procedure: surgery

• Registration Number: NCT00643877
• Lead Sponsor: Fudan University

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.

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 Timeline

• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Study Start: 2008-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25
• Primary Completion: 2009-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR	PHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
A	surgery	Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.

Primary Outcome Measures

Name	Time	Method
5 years disease-free survival	5 years after operation

Secondary Outcome Measures

Name	Time	Method
5 years overall survival and liver metastasis-free survival	5 years after operation

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China