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

Phase 1

Terminated

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

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Radiotherapy & Microwave Ablation	Stereotactic Body Radiation Therapy (SBRT)	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).
Radiotherapy & Microwave Ablation	Microwave Ablation (MWA)	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).

Primary Outcome Measures

Name	Time	Method
Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma	Until 30 days after ablation (up to 12 weeks on study)	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.

Secondary Outcome Measures

Name	Time	Method
Local Control Rate Per RECIST Criteria as Reported by Count of Participants	8 weeks	Radiologic response per RECIST criteria and volumetric measurements.
Progression Free Survival	8 weeks
Overall Survival	8 weeks
Tumor Pathology of Post-SBRT Specimen (H&E Staining)	8 weeks	H\&E staining for percentage of viable tumor remaining as measured by the presence of necrosis, fibrosis, hyalinization, and/or calcification, compared to pre-SBRT pathology