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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, One-center Study Assessing Overall Survival Using RFA Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Unresectable Colorectal Cancer Liver Metastases

Conditions
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Colorectal Cancer Liver Metastasis

Intervention / Treatment
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* Device: Radiofrequency Ablation (RFA)
* Drug: chemotherapy ± target therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>RFA plus chemotherapy ± target therapy | Device: Radiofrequency Ablation (RFA)<br>* The radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue<br>Drug: chemotherapy ± target therapy<br>* chemotherapy ± target therapy<br>|
| Active Comparator: Arm B<br>chemotherapy ± target therapy | Drug: chemotherapy ± target therapy<br>* chemotherapy ± target therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 30 days post therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, liver metastasis, Radiofrequency Ablation, chemotherapy, target therapy