BORIS - aBlação pOR mIcro-ondaS [Microwave Ablation] (BORIS)

August 2, 2023 updated by: Instituto do Cancer do Estado de São Paulo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • Instituto do Cancer do Estado de Sao Paulo
        • Contact:
          • Guilherme Lopes Pinheiro Martins, Md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microwave ablation arm
Single arm patients with lung sarcoma metastasis that will be treated with microwave ablation
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.
Other Names:
  • Image guided percutaneous lung metastasis ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 years
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).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Collaborators

Angiodynamics, Inc.

Investigators

  • Principal Investigator: Marcos Roberto de Menezes, MD, PHD, Instituto do Cancer do Estado de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP 804/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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