Clinical trial · Interventional
BORIS - aBlação pOR mIcro-ondaS [Microwave Ablation]
A Prospective, Phase III Study to Assess the Efficacy and Safety of Microwave Ablation of Metastatic Lung Sarcoma Lesions.
- 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)
Patients with sarcoma and lung metastases have few therapeutic options, with poor response to systemic treatment. Many of them are not eligible to surgical treatments due to the high number and distribution of pulmonary lesions or due to comorbidities, which reduce the survival chances of these individuals. Given the high efficacy and overall increased survival demonstrated by recent studies, the minimally invasive treatments (mainly radiofrequency ablation) have gained ground. Although the microwave ablation is a promising new technique for the treatment of patients with pulmonary metastases, there are few studies in the literature to evaluate the efficacy and safety of this procedure in the above population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image guided percutaneous microwave ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microwave ablation arm
- description
- Single arm patients with lung sarcoma metastasis that will be treated with microwave ablation
- interventionNames
- Device: Image guided percutaneous microwave ablation
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 3 years
- description
- Patients with sarcoma pulmonary metastases who are treated with microwave ablation of lung lesions may have higher overall survival rates compared to patients not subject to any kind of treatment or even chemotherapy/ palliative treatment. The literature contains data favorable to treating these patients with microwave ablation, since higher survival rates have been observed, especially when handled all lung lesions (R0).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years; * Patients with lung metastases arising from sarcoma; * Patients who are not eligible for surgery for medical reasons, including limited cardiopulmonary reserve. In this cases we will perform a pulmonary function test (PFT) to determine if the patient can withstand ablation; * Patients with recurrent metastases after pneumectomy or metastases after surgical resection. In this cases we will perform a PFT to determine if the patient can withstand ablation; * Patients with pulmonary lesions with dimensions up to 3,0 cm in the largest axial diameter; * Patients with four or fewer lesions. In cases of bilateral metastases, we will evaluate the treatment of only one lung at a time, with an interval of at least two weeks for the treatment of the contralateral lung, respecting the clinical evolution of the patient. * Patients with no extrapulmonary metastases or just indolent extrapulmonary disease; * Patients with prior histopathological confirmation of pulmonary lesions. Exclusion Criteria: * Patients with primary disease without clinical control; * Presence of uncontrolled extrapulmonary disease, including lymph node progression; * Presence of hilar lesions or near the main bronchi; * Presence of five or more lung lesions and/or lesions larger than 3,0 cm in greatest axial length; * Presence of tumors infiltrating the chest wall, mediastinal and/or pleural dissemination; * Patients with severe coagulopathy (international normalized ratio (INR) \> 1,5 or lower platelet count to 50000/mm³); * Patients with chronic obstructive pulmonary disease (COPD) stage III/ IV; * Patients with septicemia; * Patients refusing ablation treatment or participation in the study.
References
Publications (10)
- BACKGROUNDVogl TJ, Naguib NN, Gruber-Rouh T, Koitka K, Lehnert T, Nour-Eldin NE. Microwave ablation therapy: clinical utility in treatment of pulmonary metastases. Radiology. 2011 Nov;261(2):643-51. doi: 10.1148/radiol.11101643. PMID 22012906
- BACKGROUNDAbbas G, Schuchert MJ, Pennathur A, Gilbert S, Luketich JD. Ablative treatments for lung tumors: radiofrequency ablation, stereotactic radiosurgery, and microwave ablation. Thorac Surg Clin. 2007 May;17(2):261-71. doi: 10.1016/j.thorsurg.2007.03.007. PMID 17626404
- BACKGROUNDDupuy DE, Mayo-Smith WW, Abbott GF, DiPetrillo T. Clinical applications of radio-frequency tumor ablation in the thorax. Radiographics. 2002 Oct;22 Spec No:S259-69. doi: 10.1148/radiographics.22.suppl_1.g02oc03s259. PMID 12376615
- BACKGROUNDWolf FJ, Grand DJ, Machan JT, Dipetrillo TA, Mayo-Smith WW, Dupuy DE. Microwave ablation of lung malignancies: effectiveness, CT findings, and safety in 50 patients. Radiology. 2008 Jun;247(3):871-9. doi: 10.1148/radiol.2473070996. Epub 2008 Mar 27. PMID 18372457
- BACKGROUNDDupuy DE, Zagoria RJ, Akerley W, Mayo-Smith WW, Kavanagh PV, Safran H. Percutaneous radiofrequency ablation of malignancies in the lung. AJR Am J Roentgenol. 2000 Jan;174(1):57-9. doi: 10.2214/ajr.174.1.1740057. No abstract available. PMID 10628454
- BACKGROUNDSimon CJ, Dupuy DE, DiPetrillo TA, Safran HP, Grieco CA, Ng T, Mayo-Smith WW. Pulmonary radiofrequency ablation: long-term safety and efficacy in 153 patients. Radiology. 2007 Apr;243(1):268-75. doi: 10.1148/radiol.2431060088. PMID 17392258
- BACKGROUNDSuh R, Reckamp K, Zeidler M, Cameron R. Radiofrequency ablation in lung cancer: promising results in safety and efficacy. Oncology (Williston Park). 2005 Oct;19(11 Suppl 4):12-21. PMID 16366374