Status:
COMPLETED
Radiofrequency Ablation in Resectable Colorectal Lung Metastasis
Lead Sponsor:
Mie University
Conditions:
Lung Metastasis
Colorectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 use...
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 radio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00776399
Start Date
October 1 2008
End Date
August 31 2018
Last Update
March 7 2019
Active Locations (16)
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1
Anjo kosei hospital
Anjo, Aichi-ken, Japan, 446-8602
2
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
3
Hokkaido University
Sapporo, Hokkaido, Japan, 060-8648
4
Yamada red-cross hospital
Ise, Mie-ken, Japan, 516-0805