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

Primary Purpose

Colorectal Cancer Liver Metastasis

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Radiofrequency Ablation (RFA)

chemotherapy ± target therapy

About this trial

This is an interventional treatment trial for Colorectal Cancer Liver Metastasis focused on measuring colorectal cancer, liver metastasis, Radiofrequency Ablation, chemotherapy, target therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Zhongshan hosptial, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

RFA plus chemotherapy ± target therapy

chemotherapy ± target therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03127072

First Posted

April 19, 2017

Last Updated

April 23, 2017

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03127072

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 30, 2017 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer Liver Metastasis

Keywords

colorectal cancer, liver metastasis, Radiofrequency Ablation, chemotherapy, target therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

RFA plus chemotherapy ± target therapy

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

chemotherapy ± target therapy

Intervention Type

Device

Intervention Name(s)

Radiofrequency Ablation (RFA)

Intervention Description

The radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue

Intervention Type

Drug

Intervention Name(s)

chemotherapy ± target therapy

Intervention Description

chemotherapy ± target therapy

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

30 days post therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianmin Xu, PhD

Phone

+86-13501984869

xujmin@aiiyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianmin Xu, PhD

Organizational Affiliation

Fudan University

Official's Role

Study Chair

Facility Information:

Facility Name

Zhongshan hosptial, Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianmin Xu, PhD

Phone

+86-13501984869

xujmin@aiiyun.com

12. IPD Sharing Statement

Learn more about this trial

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

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