Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases

Not Applicable

Terminated

• Conditions: Neoplasm Metastasis; Hepatic Neoplasms; Colorectal Neoplasms

• Registration Number: NCT02866344
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This single-center, prospective, randomized clinical trial is designed to compare the clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to determine the optimal operative intervention for the local treatment of resectable colorectal cancer liver metastases. The primary aim of this study is to test the following hypothesis: 2-year local disease control is equivalent between patients receiving the experimental therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment for colorectal cancer liver metastases determined to be resectable by radiographic imaging. Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic disease recurrence rates are equivalent between the two treatment arms in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2021-01
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Diagnosis of adenocarcinoma of the colon or rectum (diagnosed at the time of colon or rectal resection or on endoscopic biopsy) with liver metastases (by liver biopsy or by history of biopsy-proven colon/rectal cancer with characteristic imaging findings):
• Imaging showing typical features of colorectal cancer liver metastasis;
• Cytologic/histologic diagnosis of colorectal cancer or colorectal cancer liver metastasis.
• No more than 3 hepatic metastatic lesions noted on preoperative imaging
• No lesion greater than 5 cm in maximal dimension
• Adequate clinical condition to undergo laparoscopic or robot-assisted laparoscopic liver resection or microwave ablation as treatment for colorectal cancer liver metastases
• Willing and able to give informed consent

Exclusion Criteria

• Radiologic (computed tomography or magnetic resonance imaging) evidence of invasion into major portal/hepatic venous branches and no extrahepatic metastases
• Evidence of recurrent disease adjacent to a previous ablation or resection site
• Severe renal dysfunction (creatinine clearance of <40 mL/min)
• Pregnant or nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local disease control at the site of intervention	2 years	Local disease control is measured from time of randomization and is defined as the absence of local recurrence of metastatic adenocarcinoma of the colon or rectum as determined by diagnostic imaging.

Secondary Outcome Measures

Name	Time	Method
Postoperative morbidity	1 month and 3 months
Overall survival	1, 2, 3, 5 years
Postoperative mortality	1 month and 3 months
Intrahepatic disease-free survival	1, 2, 3, 5 years

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States