Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

CT-guided Percutaneous Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502630
• Other study ID #: CRC-MW-001
• Status: Completed
• Phase: N/A
• First received: July 15, 2015
• Last updated: August 11, 2016
• Start date: June 2010
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial Summary

(MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

Description:

From June 2010 to June 2015, 48 unresectable lesions in 32 patients with pulmonary metastases from colorectal cancer were selected for CT-guided microwave ablation. Patients were scheduled for a 1 and 3 month CT follow-up to evaluate lesion diameter.We retrospectively evaluated CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Unresectable pulmonary metastases from colorectal cancer.

• diagnosis by CT, and confirmed by percutaneous puncture biopsy.

• Age range 18-70 years old.

• Eastern Cooperative Oncology Group performance status 0-1.

• Life expectancy of more than 3 months.

• Adequate organ function.

Exclusion Criteria:

• Resectable lung metastases.

• Life expectancy less than 3 months

• Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials.

• Coagulopathy with platelet count less than 50000.

• Active infectious disease.

• Age below 18 years.

• Pregnancy of breastfeeding.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• microwave ablation
pulmonary metastases from colorectal cancer are destructed/ablated using microwave ablation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		one year	Yes
Secondary	Treatment related adverse events		Eight weeks	Yes