NCT04510714

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study was designed to prospectively evaluate the safety and effectiveness of microwave ablation therapy in the treatment of metastatic lung lesions secondary to sarcoma. This technique has been proven to be successful in producing greater areas of ablation, increasing the chances of success and reducing the possibility of local recurrence, especially when compared to radiofrequency ablation. There will be 60 consecutive patients diagnosed and treated at the oncology clinic at the São Paulo State Cancer Institute that are going to participate in this study, after meeting the inclusion/ exclusion criteria. This number may be increased up to approximately about 20 patients, according to the sample behavior in the initial analysis and follow-up. All patients will be informed about the benefits, risks, complications and limitations related to the procedure and written informed consent will be applied. Patients will also be informed that microwave ablation is a new technology in Brazil, despite the extensive international experience and the results already validated in the medical literature. Logistic regression will be used to evaluate the success of the microwave ablation according to the characteristics of the lesion before the procedure. Logistic regressions for correlated data will be used to (a) evaluate the success of ablation according to all registered lesion characteristics, i.e., numeric characteristics (including tumor size and location) and categorical characteristics (histopathology of the primary tumor); (b) verify if combinations of two or more features of the lesions pose significant independent predictors for the success of ablation; and (c) construct a model to estimate the probability of success of the microwave ablation based on lesion characteristics before the procedure. The survival of patients will be assessed according to (a) the end result of the procedure (patients will be classified in two groups: an effective ablation group and a non-effective ablation group) and (b) the histopathological nature of the primary tumor. The survival rates will be calculated using the Kaplan-Meier test. The log-rank test (x² value of Cox-Mantel) will be used to determine statistically significant differences between the patients' survival rates. The value of P less than 0.05 will be considered to indicate a statistically significant difference for all analyses. Statistical software (Bias for Windows, version 8.4, Epsilon Verlag, Frankfurt, Germany) will be used.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DEVICE	Image guided percutaneous microwave ablation	Lung metastasis from sarcoma will be treated with microwave antennas (SOLERO) and Ablation System and microwave generators (Angiodynamics), with power settings of 35-45W and an average ablation time of 15 minutes (range 10-30 minutes). The ablation time will be recorded for all procedures. The manufacturer's recommendations will be observed in all cases, since it is assured that patients are able to tolerate the total ablation time.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-04-01
• Completion: 2025-10-01
• First posted: 2020-08-12
• Last updated: 2023-08-03

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated device study