Overview

This trial is active, not recruiting.

Conditions lung metastasis, colorectal cancer
Treatment lung radiofrequency ablation
Phase phase 2
Sponsor Mie University
Start date October 2008
End date April 2017
Trial size 70 participants
Trial identifier NCT00776399, 2008-993 Mie-U-IRB

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
lung radiofrequency ablation Cool-tip radiofrequency ablation system is used.
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.

Primary Outcomes

Measure
Primary Outcome Measures:3-year survival
time frame: 3 years

Secondary Outcomes

Measure
Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies
time frame: 3 years

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Mie University.