Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. (ARF2003)

Institut Bergonié

Status: Completed

Conditions: Colorectal Cancer

Treatments: Device: Ablathermy

Study type: Interventional

Funder types: Other

Identifiers

NCT00210106

ARF2003

IB2003-11

Details and patient eligibility

About

The hypothesis is that radiofrequency ablation combined or not with resection may allow a local control (the liver) in patients suffering from unresectable colorectal liver metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status < 2

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Intraoperative radiofrequency ablation (IRFA)

Experimental group

Description:

IRFA treatment, either with or without resection, was performed at laparotomy within 28 days of inclusion in the study. The type of IRFA current generator and probes, and whether or not resection was performed, was at the discretion of the surgeon.

Treatment:

Device: Ablathermy