Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776399
• Other study ID #: 2008-993 Mie-U-IRB
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: August 31, 2018

Study information

• Verified date: March 2019
• Source: Mie University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 31, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Lung Metastasis
• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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.

Locations

Country	Name	City	State
Japan	Anjo kosei hospital	Anjo	Aichi
Japan	Yamada red-cross hospital	Ise	Mie
Japan	Okayama University	Kayama	Okayama
Japan	Kumamoto University	Kumamoto
Japan	Kyoto Prefectual University of Kyoto	Kyoto
Japan	Matsusaka central hospital	Matsusaka	Mie
Japan	Matsusaka munipal hospital	Matsusaka	Mie
Japan	Aichi Cancer Center	Nagoya	Aichi
Japan	Okayama Saiseikai Hospital	Okayama
Japan	Hokkaido University	Sapporo	Hokkaidou
Japan	Suzuka central hospital	Suzuka	Mie
Japan	Suzuka Kaisei Hospital	Suzuka	Mie
Japan	Mie central medical center	Tsu	Mie
Japan	Mie University	Tsu	Mie
Japan	Toyama hospital	Tsu	Mie
Japan	Mie prefectual medical center	Yokkaichi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Mie University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measures:3-year survival		3 years
Secondary	Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies		3 years