Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases

Colorectal Neoplasms Clinical Trial

Official title:

Prospective Randomized Comparison of Resection and Microwave Ablation for Resectable Colorectal Cancer Liver Metastases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02866344
• Other study ID #: IRB00083181
• Secondary ID: 06-16-02A
• Status: Terminated
• Phase: N/A
• Start date: August 2016
• Est. completion date: February 2018

Study information

• Verified date: January 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Hepatic Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Procedure:
• Microwave ablation
Laparoscopic or robot-assisted laparoscopic microwave ablation of cancerous lesions with a 2.45-GHz microwave generator and a 1.8-mm-diameter transcutaneous antenna.
• Hepatic resection
Laparoscopic or robot-assisted laparoscopic surgical resection of cancerous lesions.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local disease control at the site of intervention	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.	2 years
Secondary	Overall survival		1, 2, 3, 5 years
Secondary	Intrahepatic disease-free survival		1, 2, 3, 5 years
Secondary	Postoperative morbidity		1 month and 3 months
Secondary	Postoperative mortality		1 month and 3 months