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

April 23, 2017 updated by: Xu jianmin, Fudan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hosptial, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm B
chemotherapy ± target therapy
Drug: chemotherapy ± target therapy
chemotherapy ± target therapy
Experimental: Arm A
RFA plus chemotherapy ± target therapy
Drug: chemotherapy ± target therapy
chemotherapy ± target therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 30 days post therapy
30 days post therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Chair: Jianmin Xu, PhD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 23, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 23, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFACRLM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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