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NCT Number: NCT00776399

Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

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.

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Key information

Conditions

Lung Metastasis Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anjo kosei hospital, Anjo, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung radiofrequency ablation

Device

A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.

Other names: Cool-tip radiofrequency ablation system is used.

Primary outcomes

  1. Primary Outcome Measures:3-year survival

    Time frame: 3 years

Secondary outcomes

  1. Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Mie University

Other

Registry information

Official study title

Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial

Important dates

Study start
2008
Primary completion
2017
Study completion
2018
First posted
Oct 21, 2008
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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