Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

NCT ID: NCT00776399

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2018-08-31

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.

Conditions

Lung Metastasis; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lung radiofrequency ablation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Cool-tip radiofrequency ablation system is used.

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mie University

OTHER

Sponsor Role: lead

Responsible Party

Koichiro Yamakado

instructor of Department of Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haruyuki Takaki, MD

Role: STUDY_DIRECTOR

Department of Radiology, Mie University School of Medicine

Locations

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

Mie University

Tsu, Mie-ken, Japan

Mie prefectual medical center

Yokkaichi, Mie-ken, Japan

Okayama University

Kayama, Okayama-ken, Japan

Kumamoto University

Kumamoto, , Japan

Kyoto Prefectual University of Kyoto

Kyoto, , Japan

Okayama Saiseikai Hospital

Okayama, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 17377185 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31934829 (View on PubMed)

Other Identifiers

2008-993 Mie-U-IRB

Identifier Type: -

Identifier Source: org_study_id