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COMPLETEDPHASE2

Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

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

NCT00776399•Mie University

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

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.
+4 more criteria

Locations (16)

Anjo kosei hospital

Anjo, Aichi-ken, Japan

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Hokkaido University

Sapporo, Hokkaido, Japan

Yamada red-cross hospital

Ise, Mie-ken, Japan

Matsusaka munipal hospital

Matsusaka, Mie-ken, Japan

Matsusaka central hospital

Matsusaka, Mie-ken, Japan

Suzuka Kaisei Hospital

Suzuka, Mie-ken, Japan

Suzuka central hospital

Suzuka, Mie-ken, Japan

Toyama hospital

Tsu, Mie-ken, Japan

Mie central medical center

Tsu, Mie-ken, Japan

Key Dates

Start Date

October 1, 2008

Primary Completion Date

December 1, 2017

Completion Date

August 31, 2018

Last Updated

March 7, 2019

Enrollment

ACTUAL participants

Conditions

Lung MetastasisColorectal Cancer

Interventions

Lung radiofrequency ablation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

Inclusion Criteria

Exclusion Criteria

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