Status:
UNKNOWN
BORIS - aBlação pOR mIcro-ondaS [Microwave Ablation]
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Collaborating Sponsors:
Angiodynamics, Inc.
Conditions:
Sarcoma
Eligibility:
All Genders
Phase:
NA
Brief 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 distri...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04510714
Start Date
June 1 2023
End Date
October 1 2025
Last Update
August 3 2023
Active Locations (1)
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1
Instituto do Câncer do Estado de São Paulo
São Paulo, Brazil, 01246-000