NCT03127072

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer Liver Metastasis

Interventions

Type	Name	Description
DEVICE	Radiofrequency Ablation (RFA)	The radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue
DRUG	chemotherapy ± target therapy	chemotherapy ± target therapy

Timeline

• Start date: 2017-04-30
• Primary completion: 2019-12-31
• Completion: 2021-12-31
• First posted: 2017-04-25
• Last updated: 2017-04-25

Locations

1 site across 1 country: China