Clinical trial NCT02866344: Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases
Official title: Prospective Randomized Comparison of Resection and Microwave Ablation for Resectable Colorectal Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Neoplasms
Neoplasm Metastasis
Hepatic Neoplasms
Keywords: Microwave ablation
Ablation techniques
Operative surgical procedures
Hepatic resection
Surgery
Outcomes assessment
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Local disease control at the site of intervention
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 1, 2, 3, 5 years
measure: Intrahepatic disease-free survival
timeFrame: 1, 2, 3, 5 years
measure: Postoperative morbidity
timeFrame: 1 month and 3 months
measure: Postoperative mortality
timeFrame: 1 month and 3 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Dionisios Vrochides, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: