Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma

NCT ID: NCT02782715

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-28
• Study Completion Date: 2023-01-10

Brief Summary

The specific aims of this study are:

1. To determine the safety and feasibility of treating patients with a combination of MRI guided stereotactic body radiation therapy and microwave ablation.

2. To assess short and long-term toxicity rates of patients treated with a combined modality approach.

3. To assess local control, survival, and pathologic response to treatment

Detailed Description

Renal cell carcinoma is traditionally managed via a surgical approach. Increasingly, local therapy with radiofrequency and microwave ablation is being utilized as an alternative for patients who may not tolerate a nephrectomy or who refuse one. Although local control rates for small lesions are excellent, they drop off precipitously for lesions over 4 cm. Furthermore, lesions in critical areas such as the renal hilum may be difficult to treat with this method. Stereotactic body radiation therapy (SBRT) has had a long record of treating patients with inoperable tumors in locations such as the lung and central nervous system, and there is increasing evidence that it may be useful for patients with renal cell carcinoma. The recent emergence of MRI-guided radiation therapy allows for direct visualization of tumors during treatment, and may potentially allow clinicians to treat tumors more precisely. This phase I study will treat renal cell carcinoma patients using a combination of MRI-guided stereotactic body radiation therapy and microwave ablation.

Conditions

Carcinoma, Renal Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy & Microwave Ablation

3+3 dose-escalation wherein three dose levels of stereotactic body radiation therapy (SBRT) would be evaluated:

1. Dose level I: 6 Gy x 5 fractions

2. Dose level II: 8 Gy x 5 fractions

3. Dose level III: 10 Gy x 5 fractions

Radiation treatments will be delivered two to three times a week, with five fractions completed over two weeks.

Four to six weeks after radiation treatment, patients will undergo repeat CT or MRI imaging to assess tumor response and suitability for microwave ablations.

Eight weeks after the conclusion of SBRT, patients will undergo microwave ablation (approximately 12 weeks after registration).

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

Patients will be treated on study with a course of SBRT treatment by a radiation oncologist. Three SBRT dose levels targeting the primary tumor will be evaluated; level I: 6 Gy x 5 fractions (a common palliative dose), level II: 8 Gy x 5 fractions, and level III: 10 Gy x 5 fractions (a common definitive dose).

Microwave Ablation (MWA)

Intervention Type: PROCEDURE

Performed under sedation using ultrasound and computed tomography (CT) guidance for percutaneous antenna placement and confirmation. Depending on size and location of tumor, one to three antennas (Certus 140; NeuWave Medical) will be used. The system is an FDA-approved, high-powered third-generation MW device that uses CO2 gas cooling to prevent shaft heating. The gas cooling allows the probes to be stuck into tissue by creating a small ice ball at the tip using the Joule-Thomson method, similar to the tissue cooling mechanism of cryoablation systems. Probes are 17-gauge, and various ablation zone configurations are available depending on the probe selected. An ablation protocol using the 65W power setting for 5 minutes will be used for most patients. Ultrasound will be used for real-time monitoring of the extent of ablation to achieve a 5mm margin beyond tumor, and immediate post-procedure imaging performed using contrast-enhanced CT (CECT) for patients with adequate renal functions.

Interventions

Stereotactic Body Radiation Therapy (SBRT)

Patients will be treated on study with a course of SBRT treatment by a radiation oncologist. Three SBRT dose levels targeting the primary tumor will be evaluated; level I: 6 Gy x 5 fractions (a common palliative dose), level II: 8 Gy x 5 fractions, and level III: 10 Gy x 5 fractions (a common definitive dose).

Intervention Type: RADIATION

Microwave Ablation (MWA)

Performed under sedation using ultrasound and computed tomography (CT) guidance for percutaneous antenna placement and confirmation. Depending on size and location of tumor, one to three antennas (Certus 140; NeuWave Medical) will be used. The system is an FDA-approved, high-powered third-generation MW device that uses CO2 gas cooling to prevent shaft heating. The gas cooling allows the probes to be stuck into tissue by creating a small ice ball at the tip using the Joule-Thomson method, similar to the tissue cooling mechanism of cryoablation systems. Probes are 17-gauge, and various ablation zone configurations are available depending on the probe selected. An ablation protocol using the 65W power setting for 5 minutes will be used for most patients. Ultrasound will be used for real-time monitoring of the extent of ablation to achieve a 5mm margin beyond tumor, and immediate post-procedure imaging performed using contrast-enhanced CT (CECT) for patients with adequate renal functions.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with imaging findings consistent with renal cell carcinoma
• Deemed medically inoperable per urology evaluation
• Tumor size >4cm in largest dimension
• ECOG performance status of <2
• Signed informed consent document(s)
• Patients with metastatic disease will not be excluded

Exclusion Criteria

• Patients who fail MRI screening
• Pregnant or nursing women
• History of prior radiation therapy to the upper abdomen
• History of invasive cancer in the last 3 years (except for appropriately treated low-rist prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer)
• Treatment with a non-approved or investigational drug within 28 days of study treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Bassetti

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://cancer.wisc.edu/

UW Carbone Cancer Center Home Page

Other Identifiers

2016-0286

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2016-00775

Identifier Type: REGISTRY

Identifier Source: secondary_id

A533300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\HUMAN ONCOLOGY\HUMAN ONCO

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 4/16/2019

Identifier Type: OTHER

Identifier Source: secondary_id

UW15103

Identifier Type: -

Identifier Source: org_study_id