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

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Colorectal Cancer Liver Metastasis

Treatments: Drug: chemotherapy ± target therapy; Device: Radiofrequency Ablation (RFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03127072

RFACRLM

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Arm A

Experimental group

Description:

RFA plus chemotherapy ± target therapy

Treatment:

Drug: chemotherapy ± target therapy

Device: Radiofrequency Ablation (RFA)

Arm B

Active Comparator group

Description:

chemotherapy ± target therapy

Treatment:

Drug: chemotherapy ± target therapy