Clinical trial · Interventional
To Evaluate Stereotactic Body Radiotherapy for Treatment of Primary Renal Cell Carcinoma Tumors
Phase I Trial of Stereotactic Body Radiotherapy (SBRT) of the Primary Tumor in Renal Cell Carcinoma (RCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor Accural
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC) in medically inoperable patients and/or patients who refuse surgery. Standard treatment of RCC is surgery. A number of non-surgical treatments of RCC are also available, but are highly invasive and are associated with significant side effects. SBRT is a non-invasive, non-surgical treatment that requires tumor immobilization and image guidance in order to deliver a very precise, high-dose treatment. This trial will assess the use of SBRT to treat primary renal tumors by determining the maximum tolerated dose and toxicity. Subjects enrolled in this study will then be followed and evaluated for toxicity, serum chemistry, complete blood count, and urinalysis. In addition, they will undergo renal scans to assess the functionality of their renal tissue.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Tumor | Primary Neoplasm | ALIAS | 0.90 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiotherapy (SBRT)
- description
- Starting dose of 48Gy in 3 fractions, will escalate dose by 2 Gy per fraction (a 6Gy total dose) to a maximum dose of 20Gy x 3 fractions (TD 60 Gy in 3 fractions).
- interventionNames
- Radiation: Stereotactic Body Radiotherapy (SBRT)
Primary outcomes (1)
- measure
- Local Failure
- timeFrame
- up to 10 years
- description
- A ≥20% increase in the sum of the diameters of the tumor with a minimum increase in the sum of 5 mm (RECIST criteria) or any areas of enhancement on follow up imaging studies is categorized as progression. Time to failure will be from the last date of SBRT to date of local failure or last follow-up. * Local failure will be classified as in field if it occurs within the treated volume or marginal if it occurs at the edge of the treated volume. * Development of a new renal tumor elsewhere in the kidney. This will not be considered a local failure. Time to development of a new tumor elsewhere in the kidney will be from the last date of SBRT to date of the event or last follow-up.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient with a primary renal cell carcinoma (RCC) tumor who is inoperable for technical (i.e surgical) or medical reasons * Patient must be screened by a urologic surgeon to verify eligibility on the above basis * Biopsy proof of RCC is preferred; however, in current practice the diagnosis is often clinical based on characteristic imaging. If there are compelling clinical reasons not to proceed with biopsy, the clinical diagnosis will suffice. * Patient with metastases are eligible if in the opinion of the treating physicians the patient could benefit from treatment of the primary renal tumor. * ECOG performance status 0-2 * Age ≥18 years * Signed informed consent Exclusion Criteria: * Inadequate renal function, as measured by creatinine clearance calculated from 24 hour urine collection. Creatinine clearance values of at least 50 ml/min are required * Prior attempt at curative treatment of this primary kidney tumor * Inability to lie still for approximately 1 hour in immobilization device * Presence of a connective tissue disorder other than rheumatoid arthritis. * Pregnancy * Inability to develop a radiation treatment plan that adheres to the dose constraints described below in Radiotherapy Treatment Planning section.
References
Publications (0)
Data not yet available