Clinical trial · Interventional
Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma
Real-time MRI-Guided Stereotactic Body Radiation Therapy and Microwave Ablation for Non-Operable Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave Ablation (MWA) | Procedure | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy & Microwave Ablation
- 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).
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
- Procedure: Microwave Ablation (MWA)
Primary outcomes (1)
- 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)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available