Clinical trial · Interventional
Assessment of Quality of Life and Outcomes in Patients With Primary Renal Cell Carcinoma Treated With SBRT
Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiotherapy (SBRT) for Inoperable Renal Cell Carcinoma (RCC): A Multicenter Phase II Study
NCT05023265CI-TRIAL-00109656AQuOS-IIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, single arm phase II study of stereotactic body radiation therapy (SBRT) for patients with medically inoperable primary renal cell carcinoma (RCC).
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT for Medically Inoperable RCC
- description
- 35-45 Gy in five fractions (7-9 Gy/day)
- interventionNames
- Radiation: Stereotactic body radiotherapy
Primary outcomes (1)
- measure
- Local Control at 2 years
- timeFrame
- 2 years
- description
- Local control at 2 years defined as the absence of progression of disease of the treated primary kidney cancer using Responsive Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Secondary outcomes (4)
- measure
- Severity of late treatment-related toxicity
- timeFrame
- 6-60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥18 years old * Newly diagnosed RCC by biopsy (preferred) or radiologic evidence of growth on surveillance over two consecutive assessments (6-12 months) * Primary lesion \>3 cm, or recurrent lesion following local ablative therapy * Medically inoperable or patient who refuses surgery following assessment by experienced urologist, and discussed in a multidisciplinary setting * ECOG 0-2 * Written informed consent * Participants must be able to understand the English-language or with the aid of a translator Exclusion Criteria: * Primary Lesion \>20cm * Evidence of distant metastatic disease * Previous abdominal RT in vicinity of kidney preventing definitive SBRT * History of major radiosensitivity syndrome * Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer) * Currently pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.