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

NCT02782715 | Terminated Phase 1 Results DMC FDA Device

• 6 other identifiers: UW151032016-0286NCI-2016-00775A533300SMPH\HUMAN ONCOLOGY\HUMAN ONCOProtocol Version 4/16/2019
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of this study are:

1. 1.To determine the safety and feasibility of treating patients with a combination of MRI guided stereotactic body radiation therapy and microwave ablation.
2. 2.To assess short and long-term toxicity rates of patients treated with a combined modality approach.
3. 3.To assess local control, survival, and pathologic response to treatment

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

• Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma

  Dose-limiting toxicity (DLT) will be defined as grade 4 or higher non-hematologic toxicity attributable to treatment. This will exclude toxicities not caused by treatment, such as pain due to tumor progression. Toxicities will be defined per NCI CTCAE v5.0.

  Until 30 days after ablation (up to 12 weeks on study)

Secondary Outcomes (4)

• Local Control Rate Per RECIST Criteria as Reported by Count of Participants

  8 weeks

• Progression Free Survival

  8 weeks

• Overall Survival

  8 weeks

• Tumor Pathology of Post-SBRT Specimen (H&E Staining)

  8 weeks

Other Outcomes (1)

• Tumor Pathology of Post-SBRT Specimen (Pathologic Evaluation)

  8 weeks

Study Arms (1)

Radiotherapy & Microwave Ablation

EXPERIMENTAL

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).

Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Microwave Ablation (MWA)

Interventions

Stereotactic Body Radiation Therapy (SBRT) 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).

Radiotherapy & Microwave Ablation

Microwave Ablation (MWA) 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.

Radiotherapy & Microwave Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

Related Links

• UW Carbone Cancer Center Home Page

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Michael Bassetti, MD, PhD
• Organization: University of Wisconsin School of Medicine and Public Health

bassetti@humonc.wisc.edu

608-263-8500

Study Officials

• Michael Bassetti

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 25, 2016
• Study Start: June 28, 2018
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: March 20, 2024
• Results First Posted: March 20, 2024

Record last verified: 2024-02

Locations

US (1)