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

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Colorectal Neoplasms

Treatments: Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR; Procedure: surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00643877

2008-46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

B

Experimental group

Description:

PHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.

Treatment:

Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR

A

No Intervention group

Description:

Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.

Treatment:

Procedure: surgery