Microwave ablation for lung metastases from sarcoma

A Prospective, Phase III Study to Assess the Efficacy and Safety of Microwave Ablation of Metastatic Lung Sarcoma Lesions.

This study is testing if microwave ablation therapy can safely and effectively treat lung tumors from sarcoma in patients who can’t have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sex: All
• Sponsor: Instituto do Cancer do Estado de São Paulo (Academic / other)
• Locations: 1 site (São Paulo)
• Trial ID: NCT04510714 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of microwave ablation therapy for patients with lung metastases secondary to sarcoma, particularly those who are not candidates for surgery. The study will involve 60 patients treated at the São Paulo State Cancer Institute, focusing on the technique's ability to produce larger ablation areas compared to traditional methods. Patients will undergo thorough assessments, including pulmonary function tests, to ensure they can tolerate the procedure. The outcomes will be analyzed using logistic regression to determine the success rates based on lesion characteristics.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with lung metastases from sarcoma who are not eligible for surgery due to medical reasons.

Not a fit: Patients with extensive extrapulmonary metastases or those with pulmonary lesions larger than 3.0 cm will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a minimally invasive option for patients with limited therapeutic choices and improve survival rates.

How similar studies have performed: While microwave ablation is a promising technique, there are few studies specifically evaluating its efficacy in this patient population, making this approach relatively novel.

Eligibility criteria

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.

Where this trial is running

São Paulo

• Instituto do Câncer do Estado de São Paulo — São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Marcos Roberto de Menezes, MD, PHD — Instituto do Cancer do Estado de Sao Paulo
• Study coordinator: Guilherme Lopes Pinheiro Martins, MD

Conditions Sarcoma; Percutaneous ablation; Lung ablation; Microwave ablation