Back to results

Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC)

Primary Purpose

Secondary Malignant Neoplasm of Liver

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CRLM resection group

CRLM ablation group

About this trial

This is an interventional treatment trial for Secondary Malignant Neoplasm of Liver focused on measuring synchronous, metachronous, colorectal liver metastasis, resection, ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least one metastatic adenocarcinoma of liver, histologically proven.
At least one adenocarcinoma of colon and/or rectum, histologically proven.
No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion).
No extra-hepatic metastasis.
Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated.
All the primary and secondary tumors which R0 resections are technically possible. (SCRLM: synchronous resection for both primary and secondary tumors, MCRLM: no local recurrence within 6 months after resection of primary tumor)
Residual hepatic volume>30%-40%.
At least 2-3 hepatic segments remained after hepatectomy (except S1), residual liver with normal portal vein, hepatic artery and biliary duct, at least 1 of hepatic veins (left, middle and right) not invaded.
Tumor size ≤3 cm.
Tumor number≤ 3.
Tumors located ≥1.0 cm of vulnerable structures, e.g. colon, main trunk of portal vein, hepatic artery, hepatic vein and intrahepatic biliary duct.
suitable for both hepatectomy and local ablation after multiple disciplinary team(MDT) discussion.
Informed written consent.

Exclusion Criteria:

Other malignant tumors history.
Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.).
Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately.
≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40%
Non resectable lymph node metastasis.
American Society of Anesthesiologists(ASA) grading≥ IV and/or Eastern cooperative oncology group(ECOG) score≥ 2. (see appendix)
EHD is not recommended.
Physical or psychological dependence.
Pregnant or breast feeding women.
Not controlled preoperational infection.
Enrolled in other clinical trials within 4 weeks. Other clinical or laboratorial condition not recommended by investigators.

Sites / Locations

The 6th Affiliated Hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CRLM resection group

CRLM ablation group

Arm Description

Resection of both primary and secondary tumors in SCRLM and resection of MCRLM. Interventions: Simultaneous resection of both primary and secondary tumors in SCRLM and resection of MCRLM.

Ablation of CRLM after resection of primary tumor in SCRLM and ablation of MCRLM. Interventions: Ablation of liver metastasis within 30 days after resection of primary tumor in SCRLM and ablation of MCRLM.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

R0 resection rate in both primary and secondary tumor in CRLM

Death rate during hospitalization or within 30 days after surgery/ablation

Rate of patients with at least one postoperative severe complication within 30 days after surgery/ablation

Disease-free survival and 1, 2 and 3-years disease-free survival rate

Complete ablation rate in CRLM

Full Information

NCT ID

NCT02886104

First Posted

August 24, 2016

Last Updated

August 28, 2016

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT02886104

Brief Title

Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis

Acronym

HELARC

Official Title

Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC) ------ a Randomized Controlled Multicenter Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Recruiting

Study Start Date

August 2016 (undefined)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The surgical and local ablation strategy for the treatment of resectable synchronous and metachronous colorectal liver metastases(CRLM) has not still been defined. The purpose of this study is to compare two treatment strategies in which simultaneous resection of both primary and secondary tumor of synchronous CRLM(SCRLM) and resection of metachronous CRLM(MCRLM) is compared with resection of primary tumor and ablation of secondary tumor in SCRLM and ablation of MCRLM. Endpoints include the rate of severe complications and survival.

Detailed Description

Colorectal cancer(CRC) kills more than 700,000 patients every year, which is nowadays the world's 3rd common and the 4th deadly tumor. About 50% CRC patients will finally develop colorectal liver metastasis (CRLM). Among the CRLM patients, 20-25% of CRC are found with synchronous colorectal liver metastases (SCRLM) at the first visit. Meanwhile, about 20-30% CRC patients suffer by metachronous colorectal liver metastasis (MCRLM) even after radical resection of primary tumor. It is nowadays admitted that the R0 resection of both primary and secondary tumors in SCRLM and R0 resection of MCRLM represents a feasible and potential curative treatment in patients with resectable CRLM(RCRLM). However, the treatment strategy for some RCRLM (tumor number≤3 and tumor size≤3.0cm), such as whether to choose hepatectomy or local ablation, still remains in debate. In primary hepatocellular carcinoma(HCC), local ablation has been proved to has similar curative effect to that of hepatectomy. Compared to hepatectomy, local ablation has less trauma and more rapid recovery and possible lower hospitalization cost. The curative effect of local ablation is mainly influenced by tumor site and tumor size. On the other side, some RCRLM might develop repeat recurrences even after "R0" resection due to the imaging undetectable micro metastasis. Thus, local ablation might be more suitable for some repeat recurrent CRLM. The aim of this study is to compare the efficacy/safety of local ablation with hepatectomy for RCRLM (tumor number≤3, tumor size≤3.0cm), including both SCRLM and MCRLM. Patients are randomized to CRLM resection group and local ablation group. The primary endpoint is overall survival. Secondary endpoints evaluate the rate of patients with at least one severe complication within 30 days after surgery/ablation and long-term clinical outcomes, in particular disease-free survival.

6. Conditions and Keywords

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

Secondary Malignant Neoplasm of Liver

Keywords

synchronous, metachronous, colorectal liver metastasis, resection, ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

548 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CRLM resection group

Arm Type

Active Comparator

Arm Description

Resection of both primary and secondary tumors in SCRLM and resection of MCRLM. Interventions: Simultaneous resection of both primary and secondary tumors in SCRLM and resection of MCRLM.

Arm Title

CRLM ablation group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

CRLM resection group

Other Intervention Name(s)

Hepatectomy

Intervention Description

Simultaneous resection of both primary and secondary tumors in synchronous CRLM or resection of metachronous CRLM.

Intervention Type

Device

Intervention Name(s)

CRLM ablation group

Other Intervention Name(s)

Microwave ablation

Intervention Description

Microwave ablation of CRLM with a 2.15-gigahertz(GHz) microwave generator and a 14 gauge diameter transcutaneous antenna within 30 days after resection of primary tumor in synchronous CRLM or ablation of metachronous CRLM.

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

R0 resection rate in both primary and secondary tumor in CRLM

Time Frame

Day of surgery

Title

Death rate during hospitalization or within 30 days after surgery/ablation

Time Frame

30 days after surgery/ablation

Title

Rate of patients with at least one postoperative severe complication within 30 days after surgery/ablation

Time Frame

30 days after surgery/ablation

Title

Disease-free survival and 1, 2 and 3-years disease-free survival rate

Time Frame

1, 2 and 3-years

Title

Complete ablation rate in CRLM

Time Frame

Day of ablation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least one metastatic adenocarcinoma of liver, histologically proven. At least one adenocarcinoma of colon and/or rectum, histologically proven. No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion). No extra-hepatic metastasis. Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated. All the primary and secondary tumors which R0 resections are technically possible. (SCRLM: synchronous resection for both primary and secondary tumors, MCRLM: no local recurrence within 6 months after resection of primary tumor) Residual hepatic volume>30%-40%. At least 2-3 hepatic segments remained after hepatectomy (except S1), residual liver with normal portal vein, hepatic artery and biliary duct, at least 1 of hepatic veins (left, middle and right) not invaded. Tumor size ≤3 cm. Tumor number≤ 3. Tumors located ≥1.0 cm of vulnerable structures, e.g. colon, main trunk of portal vein, hepatic artery, hepatic vein and intrahepatic biliary duct. suitable for both hepatectomy and local ablation after multiple disciplinary team(MDT) discussion. Informed written consent. Exclusion Criteria: Other malignant tumors history. Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.). Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately. Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately. ≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40% Non resectable lymph node metastasis. American Society of Anesthesiologists(ASA) grading≥ IV and/or Eastern cooperative oncology group(ECOG) score≥ 2. (see appendix) EHD is not recommended. Physical or psychological dependence. Pregnant or breast feeding women. Not controlled preoperational infection. Enrolled in other clinical trials within 4 weeks. Other clinical or laboratorial condition not recommended by investigators.

Central Contact Person:

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

Meijin Huang, MD,PHD

Phone

+8613924073322

maymay0129@139.com

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

Jun Huang, MD,PHD

Phone

+8613926451242

huangj97@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meijin Huang, MD,PHD

Organizational Affiliation

The 6th Affiliated Hospital of Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The 6th Affiliated Hospital of Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meijin Huang, MD,PHD

Phone

+8613924073322

maymay0129@139.com

First Name & Middle Initial & Last Name & Degree

Jun Huang, MD,PHD

Phone

+8613926451242

huangj97@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25970450

Citation

Brody H. Colorectal cancer. Nature. 2015 May 14;521(7551):S1. doi: 10.1038/521S1a. No abstract available.

Results Reference

background

PubMed Identifier

25073464

Citation

Joranger P, Nesbakken A, Hoff G, Sorbye H, Oshaug A, Aas E. Modeling and validating the cost and clinical pathway of colorectal cancer. Med Decis Making. 2015 Feb;35(2):255-65. doi: 10.1177/0272989X14544749. Epub 2014 Jul 29.

Results Reference

background

PubMed Identifier

19470929

Citation

Kopetz S, Chang GJ, Overman MJ, Eng C, Sargent DJ, Larson DW, Grothey A, Vauthey JN, Nagorney DM, McWilliams RR. Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy. J Clin Oncol. 2009 Aug 1;27(22):3677-83. doi: 10.1200/JCO.2008.20.5278. Epub 2009 May 26.

Results Reference

background

PubMed Identifier

21771709

Citation

Bethke A, Kuhne K, Platzek I, Stroszczynski C. Neoadjuvant treatment of colorectal liver metastases is associated with altered contrast enhancement on computed tomography. Cancer Imaging. 2011 Jun 29;11(1):91-9. doi: 10.1102/1470-7330.2011.0015.

Results Reference

background

PubMed Identifier

19890600

Citation

Livraghi T. Single HCC smaller than 2 cm: surgery or ablation: interventional oncologist's perspective. J Hepatobiliary Pancreat Sci. 2010 Jul;17(4):425-9. doi: 10.1007/s00534-009-0244-x. Epub 2009 Nov 5.

Results Reference

background

Learn more about this trial

Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis

We'll reach out to this number within 24 hrs