Clinical trial · Interventional
Radiofrequency Ablation in Resectable Colorectal Lung Metastasis
Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
NCT00776399CI-TRIAL-00037495completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lung Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lung radiofrequency ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lung radiofrequency ablation
- description
- A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
- interventionNames
- Device: Lung radiofrequency ablation
Primary outcomes (1)
- measure
- Primary Outcome Measures:3-year survival
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDYamakado 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. PMID 17377185
- DERIVEDHasegawa 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. PMID 31934829