Microwave Ablation for Pulmonary Metastases From Colorect... | NCT02502630

Studies
Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

NCT02502630

Sponsor

The First People's Hospital of Changzhou

Status

Completed

Last Update Posted

Aug 15, 2016Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

microwave ablation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jul 15, 2015

First Submission Date that Met QC Criteria

Jul 16, 2015

First Posted Date

Jul 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2016

Last Update Posted Date

Aug 15, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treated with microwave ablation	Experimental	Patients undergoing MWA for pulmonary metastases from colorectal cancer.	Device: microwave ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
microwave ablation	Device	pulmonary metastases from colorectal cancer are destructed/ablated using microwave ablation	Treated with microwave ablation

Measure	Description	Time Frame
Overall Survival (OS)		one year

Measure	Description	Time Frame
Treatment related adverse events		Eight weeks

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jingting Jiang, PD	The First People's Hospital of Changzhou	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28847194	Derived	Cheng G, Shi L, Qiang W, Wu J, Ji M, Lu Q, Li X, Xu B, Jiang J, Wu C. The safety and efficacy of microwave ablation for the treatment of CRC pulmonary metastases. Int J Hyperthermia. 2018 Jun;34(4):486-491. doi: 10.1080/02656736.2017.1366553. Epub 2017 Nov 16.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site