Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM

Fudan University200 enrolled

Overview

To date no prospective trials have been completed that demonstrated whether RFA is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in overall survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine overall survival for patients with colorectal cancer liver metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Colorectal Cancer Liver Metastasis

Interventions

Radiofrequency Ablation (RFA)DEVICE

The radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue

chemotherapy ± target therapyDRUG

chemotherapy ± target therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: All patients must meet the following criteria: Patients must have incurable CRLM Patients must have no more than 10 liver metastases (LMs) remaining after surgical resection, with diameter less than 5cm Patients is medically eligible to receive RFA, as determined by the MDT (multidisciplinary team) Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Age \> 18 years Subject life expectancy \> 3 months Platelets \> 100×103/mm3 Total bilirubin \<1.5mg/dl Creatinine level \< 2.0 mg/dl All patients must sign an informed consent form Exclusion Criteria: The CRLM is amenable to curative surgical therapy Uncorrectable coagulopathy Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival Current or planned treatment with any experimental chemotherapy or target drugs

Locations (1)

Zhongshan hosptial, Fudan University

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Overall survival in subjects receiving RFA plus chemotherapy ± target therapy compared to chemotherapy ± target therapy alone was assessed from the date of study entry until death from the disease.

Time frame: 3 years

Secondary Outcomes

The differences in the incidence or severity of adverse events in the RFA plus chemotherapy ± target therapy arm compared to the chemotherapy ± target therapy only arm were was assessed by of complications after therapy.

Time frame: 30 days post therapy

Central Contacts

Jianmin Xu, PhD

CONTACT

+86-13501984869 xujmin@aiiyun.com

Data from ClinicalTrials.gov

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