NCT02502630

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable colorectal-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

5 years

First QC Date

July 15, 2015

Last Update Submit

August 11, 2016

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    one year

Secondary Outcomes (1)

  • Treatment related adverse events

    Eight weeks

Study Arms (1)

Treated with microwave ablation

EXPERIMENTAL

Patients undergoing MWA for pulmonary metastases from colorectal cancer.

Device: microwave ablation

Interventions

microwave ablationDEVICE

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

Treated with microwave ablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28847194DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jingting Jiang, PD

    The First People's Hospital of Changzhou

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 20, 2015

Study Start

June 1, 2010

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

August 15, 2016

Record last verified: 2016-08