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

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Carcinoma, Renal Cell

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02782715

Protocol Version 4/16/2019 (Other Identifier)

UW15103

2016-0286 (Other Identifier)

A533300 (Other Identifier)

NCI-2016-00775 (Registry Identifier)

SMPH\HUMAN ONCOLOGY\HUMAN ONCO (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Radiotherapy & Microwave Ablation

Experimental group

Description:

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).

Treatment:

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Procedure: Microwave Ablation (MWA)