Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: 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 phase-II trial, clinical utility of lung RF ablation will be evaluated in patients with resectable colorectal lung metastases.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Lung Metastasis
• Intervention / Treatment: Device: Lung radiofrequency ablation

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: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Kumamoto, Japan, 860-8505
    • Kumamoto University
  • Kyoto, Japan, 602-8566
    • Kyoto Prefectual University of Kyoto
  • Okayama, Japan, 700-8511
    • Okayama Saiseikai Hospital
  • Aichi
    • Anjo, Aichi, Japan, 446-8602
      • Anjo Kosei Hospital
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi Cancer Center
  • Hokkaidou
    • Sapporo, Hokkaidou, Japan, 060-8648
      • Hokkaido University
  • Mie
    • Ise, Mie, Japan, 516-0805
      • Yamada red-cross hospital
    • Matsusaka, Mie, Japan, 515-0073
      • Matsusaka munipal hospital
    • Matsusaka, Mie, Japan, 515-8566
      • Matsusaka central hospital
    • Suzuka, Mie, Japan, 513-8505
      • Suzuka Kaisei Hospital
    • Suzuka, Mie, Japan, 513-8630
      • Suzuka central hospital
    • Tsu, Mie, Japan, 514-0043
      • Toyama hospital
    • Tsu, Mie, Japan, 514-1101
      • Mie central medical center
    • Tsu, Mie, Japan, 514-8507
      • Mie University
    • Yokkaichi, Mie, Japan, 510-8561
      • Mie prefectual medical center
  • Okayama
    • Kayama, Okayama, Japan, 700-8558
      • Okayama University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: Cool-tip radiofrequency ablation system is used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Outcome Measures:3-year survival	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mie University
• Investigators: Study Director: Haruyuki Takaki, MD, Department of Radiology, Mie University School of Medicine

Publications and helpful links

General Publications

• Yamakado K, Hase S, Matsuoka T, Tanigawa N, Nakatsuka A, Takaki H, Takao M, Inoue Y, Kanazawa S, Inoue Y, Sawada S, Kusunoki M, Takeda K. Radiofrequency ablation for the treatment of unresectable lung metastases in patients with colorectal cancer: a multicenter study in Japan. J Vasc Interv Radiol. 2007 Mar;18(3):393-8. doi: 10.1016/j.jvir.2006.11.003.
• Hasegawa T, Takaki H, Kodama H, Yamanaka T, Nakatsuka A, Sato Y, Takao M, Katayama Y, Fukai I, Kato T, Tokui T, Tempaku H, Adachi K, Matsushima Y, Inaba Y, Yamakado K. Three-year Survival Rate after Radiofrequency Ablation for Surgically Resectable Colorectal Lung Metastases: A Prospective Multicenter Study. Radiology. 2020 Mar;294(3):686-695. doi: 10.1148/radiol.2020191272. Epub 2020 Jan 14.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: October 17, 2008
• First Submitted That Met QC Criteria: October 20, 2008
• First Posted (Estimate): October 21, 2008

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: radiofrequency ablation; Colorectal cancer; metastasectomy; lung metastasis; Lung metastasis from colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Lung Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
• Other Study ID Numbers: 2008-993 Mie-U-IRB