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

Phase 4

• Conditions: Colorectal Cancer Liver Metastasis
• Interventions: Device: Radiofrequency Ablation (RFA); Drug: chemotherapy ± target therapy

• Registration Number: NCT03127072
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-23
• Last Update Submitted: 2017-04-23
• Study First Posted: 2017-04-25
• Last Update Posted: 2017-04-25
• Study Start: 2017-04-30
• Primary Completion: 2019-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	chemotherapy ± target therapy	RFA plus chemotherapy ± target therapy
Arm B	chemotherapy ± target therapy	chemotherapy ± target therapy
Arm A	Radiofrequency Ablation (RFA)	RFA plus chemotherapy ± target therapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongshan hosptial, Fudan University; 🇨🇳 Shanghai, China