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

Colorectal Cancer Liver Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03127072
• Other study ID #: RFACRLM
• Status: Recruiting
• Phase: Phase 4
• First received: April 19, 2017
• Last updated: April 23, 2017
• Start date: April 30, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2017
• Source: Fudan University
• Contact: Jianmin Xu, PhD
• Phone: +86-13501984869
• Email: xujmin[@]aiiyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Liver Metastasis
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan hosptial, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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