Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

Phase 2

Completed

• Conditions: Lung Metastasis; Colorectal Cancer
• Interventions: Device: Lung radiofrequency ablation

• Registration Number: NCT00776399
• Lead Sponsor: Mie University

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Primary Completion: 2017-12-01
• Study Completion: 2018-08-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung radiofrequency ablation	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.

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures:3-year survival	3 years

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies	3 years

Trial Locations

Locations (16)

Toyama hospital; 🇯🇵 Tsu, Mie, Japan

Mie central medical center; 🇯🇵 Tsu, Mie, Japan

Kyoto Prefectual University of Kyoto; 🇯🇵 Kyoto, Japan

Kumamoto University; 🇯🇵 Kumamoto, Japan

Okayama University; 🇯🇵 Kayama, Okayama, Japan

Okayama Saiseikai Hospital; 🇯🇵 Okayama, Japan

Mie prefectual medical center; 🇯🇵 Yokkaichi, Mie, Japan

Matsusaka central hospital; 🇯🇵 Matsusaka, Mie, Japan

Suzuka Kaisei Hospital; 🇯🇵 Suzuka, Mie, Japan

Suzuka central hospital; 🇯🇵 Suzuka, Mie, Japan

Mie University; 🇯🇵 Tsu, Mie, Japan

Anjo kosei hospital; 🇯🇵 Anjo, Aichi, Japan

Aichi Cancer Center; 🇯🇵 Nagoya, Aichi, Japan

Yamada red-cross hospital; 🇯🇵 Ise, Mie, Japan

Hokkaido University; 🇯🇵 Sapporo, Hokkaidou, Japan

Matsusaka munipal hospital; 🇯🇵 Matsusaka, Mie, Japan