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

Fudan University600 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

600

Conditions

Colorectal Neoplasms

Interventions

Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDRPROCEDURE

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

surgeryPROCEDURE

radical surgery only

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

5 years disease-free survival

Time frame: 5 years after operation

Secondary Outcomes

5 years overall survival and liver metastasis-free survival

Time frame: 5 years after operation

Central Contacts

jianmin xu, MD

CONTACT

008613501984869 xujmin@yahoo.com.cn

Data from ClinicalTrials.gov

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