Clinical trial NCT02782715: Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma
Official title: Real-time MRI-Guided Stereotactic Body Radiation Therapy and Microwave Ablation for Non-Operable Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Renal Cell
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma
timeFrame: Until 30 days after ablation (up to 12 weeks on study)
Secondary outcomes:
measure: Local Control Rate Per RECIST Criteria as Reported by Count of Participants
timeFrame: 8 weeks
measure: Progression Free Survival
timeFrame: 8 weeks
measure: Overall Survival
timeFrame: 8 weeks
measure: Tumor Pathology of Post-SBRT Specimen (H&E Staining)
timeFrame: 8 weeks
Other outcomes:
measure: Tumor Pathology of Post-SBRT Specimen (Pathologic Evaluation)
timeFrame: 8 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Bassetti
role: PRINCIPAL_INVESTIGATOR
References: