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Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00776399
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Koichiro Yamakado, Mie University

Tracking Information
First Submitted Date  ICMJE October 17, 2008
First Posted Date  ICMJE October 21, 2008
Last Update Posted Date March 7, 2019
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Primary Outcome Measures:3-year survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiofrequency Ablation in Resectable Colorectal Lung Metastasis
Official Title  ICMJE Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
Brief Summary Lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In this phase-II trial, clinical utility of lung RF ablation will be evaluated in patients with resectable colorectal lung metastases.
Detailed Description

This will be a phase-II clinical trial.

Lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In this clinical trial, clinical utility of lung RF ablation will be evaluated.

Patients with resectable lung metastases will receive lung RF ablation.

All subjects will be followed for overall survival, safety, change in respiratory function, cancer-specific survival, and local tumor progression.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Metastasis
  • Colorectal Cancer
Intervention  ICMJE Device: Lung radiofrequency ablation
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
Other Name: Cool-tip radiofrequency ablation system is used.
Study Arms  ICMJE Experimental: Lung radiofrequency ablation
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
Intervention: Device: Lung radiofrequency ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2009)
70
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2008)
110
Actual Study Completion Date  ICMJE August 31, 2018
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Primary lesions (colorectal cancer) are resected.
  • Lung metastases appear.
  • No extrapulmonary metastases or after locoregional treatments.
  • Lung metastasis is considered to be controllable either by metastasectomy or radiofrequency (RF) ablation.
  • Five or less lung metastases measuring 3cm or smaller.
  • PET study within 8 weeks before metastasectomy or RF ablation.
  • White blood count of 3000/mm3 or more.
  • Platelet count of 100,000/mm3 or more.
  • Hemoglobin level of 8.0 g/dl.
  • Serum creatinine level of 2.0 mg/dl or less.
  • PaO2 of 70 mm Hg or more(Room air)or SpO2 of 93%.
  • Serum bilirubin level of 2.0 mg/dl or less.
  • Performance status of 0 or 1.
  • Expected survival of 1 year or more.
  • Age of 20 years or more.
  • Informed consent from the patient.

Exclusion Criteria:

  • Risk to injure lung vessels 5 mm or larger.
  • Lung metastases adjacent to the heart, trachea, esophagus, and aorta.
  • Association of uncontrollable malignancies.
  • Lung hilar lymph node metastasis.
  • One lung.
  • Pulmonary hypertension.
  • Coagulopathy.
  • Impossible to stop using anticoagulants.
  • Active infection or C-reactive protein of 3 or higher.
  • Association of active inflammation.
  • Fever (higher than 38 degrees celsius).
  • Previous external-beam radiotherapy for the treated lung.
  • Pregnant.
  • Judgment to be an inappropriate candidate by a attending physician.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776399
Other Study ID Numbers  ICMJE 2008-993 Mie-U-IRB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Koichiro Yamakado, Mie University
Study Sponsor  ICMJE Mie University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Haruyuki Takaki, MD Department of Radiology, Mie University School of Medicine
PRS Account Mie University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP