Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
20 Years
N/A
Both
Lung Metastasis, Colorectal Cancer
Trial Information
Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary Outcome Measures:3-year survival
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Haruyuki Takaki, MD
Investigator Role:
Study Director
Investigator Affiliation:
Department of Radiology, Mie University School of Medicine
Authority:
Japan: Institutional Review Board
Study ID:
2008-993 Mie-U-IRB
NCT ID:
NCT00776399
Start Date:
October 2008
Completion Date:
November 2014
Related Keywords:
- Lung Metastasis
- Colorectal Cancer
- Colorectal cancer
- lung metastasis
- radiofrequency ablation
- metastasectomy
- Lung metastasis from colorectal cancer
- Colorectal Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Lung Neoplasms
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