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Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

Primary Purpose

Lung Metastasis, Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Lung radiofrequency ablation
Sponsored by
Mie University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Metastasis focused on measuring Colorectal cancer, lung metastasis, radiofrequency ablation, metastasectomy, Lung metastasis from colorectal cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
  • 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.

Sites / Locations

  • Anjo kosei hospital
  • Aichi Cancer Center
  • Hokkaido University
  • Yamada red-cross hospital
  • Matsusaka munipal hospital
  • Matsusaka central hospital
  • Suzuka Kaisei Hospital
  • Suzuka central hospital
  • Toyama hospital
  • Mie central medical center
  • Mie University
  • Mie prefectual medical center
  • Okayama University
  • Kumamoto University
  • Kyoto Prefectual University of Kyoto
  • Okayama Saiseikai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lung radiofrequency ablation

Arm Description

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

Outcomes

Primary Outcome Measures

Primary Outcome Measures:3-year survival

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2008
Last Updated
March 5, 2019
Sponsor
Mie University
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1. Study Identification

Unique Protocol Identification Number
NCT00776399
Brief Title
Radiofrequency Ablation in Resectable Colorectal Lung Metastasis
Official Title
Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mie University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Metastasis, Colorectal Cancer
Keywords
Colorectal cancer, lung metastasis, radiofrequency ablation, metastasectomy, Lung metastasis from colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lung radiofrequency ablation
Arm Type
Experimental
Arm Description
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
Intervention Type
Device
Intervention Name(s)
Lung radiofrequency ablation
Other Intervention Name(s)
Cool-tip radiofrequency ablation system is used.
Intervention Description
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
Primary Outcome Measure Information:
Title
Primary Outcome Measures:3-year survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haruyuki Takaki, MD
Organizational Affiliation
Department of Radiology, Mie University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Anjo kosei hospital
City
Anjo
State/Province
Aichi
ZIP/Postal Code
446-8602
Country
Japan
Facility Name
Aichi Cancer Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Hokkaido University
City
Sapporo
State/Province
Hokkaidou
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Yamada red-cross hospital
City
Ise
State/Province
Mie
ZIP/Postal Code
516-0805
Country
Japan
Facility Name
Matsusaka munipal hospital
City
Matsusaka
State/Province
Mie
ZIP/Postal Code
515-0073
Country
Japan
Facility Name
Matsusaka central hospital
City
Matsusaka
State/Province
Mie
ZIP/Postal Code
515-8566
Country
Japan
Facility Name
Suzuka Kaisei Hospital
City
Suzuka
State/Province
Mie
ZIP/Postal Code
513-8505
Country
Japan
Facility Name
Suzuka central hospital
City
Suzuka
State/Province
Mie
ZIP/Postal Code
513-8630
Country
Japan
Facility Name
Toyama hospital
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-0043
Country
Japan
Facility Name
Mie central medical center
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-1101
Country
Japan
Facility Name
Mie University
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Mie prefectual medical center
City
Yokkaichi
State/Province
Mie
ZIP/Postal Code
510-8561
Country
Japan
Facility Name
Okayama University
City
Kayama
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kumamoto University
City
Kumamoto
ZIP/Postal Code
860-8505
Country
Japan
Facility Name
Kyoto Prefectual University of Kyoto
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Okayama Saiseikai Hospital
City
Okayama
ZIP/Postal Code
700-8511
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17377185
Citation
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.
Results Reference
background
PubMed Identifier
31934829
Citation
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.
Results Reference
derived

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Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

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