Stereotactic Body Radiation Therapy for Renal Tumors: A Prospective Phase 2 Clinical Trial
Bibliographic record
Abstract
Background Stereotactic body radiotherapy (SBRT) represents a novel, efficacious treatment for patients with kidney tumors who are medically inoperable or decline surgery. There is limited prospective data on the impact of kidney SBRT on renal function. Methods This was a prospective phase II single-arm clinical trial (clinicaltrials.gov NCT03747133) of kidney-directed SBRT in patients with primary or metastatic renal lesions who were medically inoperable or declined surgery. The primary outcome was change in kidney function, assessed by change in eGFR over 2 years. The a priori hypothesis was that eGFR (mL/min/1.73m 2 ) does not decrease over time and was analyzed using a one sample t-test for non-inferiority with a fixed margin of -6.974 based on published data at time of trial design. Results Thirty patients with 32 renal tumors enrolled, with median (IQR) age 76 (73-82), Charlson comorbidity index 8 (7-9), 93% with chronic kidney disease (CKD) stage ≥2 (eGFR ≤60 mL/min/1.73 m 2 ), and majority with cT1b disease with median tumor size 43 mm. Twenty-six patients (87%) had primary kidney cancer, and the remainder had non-kidney cancer metastatic lesions. Median radiation dose was 35 Gy in 5 fractions. Median follow-up was 24.5 months (IQR 20-36.2). Median (IQR) eGFR levels (mL/min/1.73m 2 ) were 47.5 (37.8-64.0) at baseline, 42.0 (35.2-54.2) at 1-year and 39.5 (25.5-54.8) at 2-years. Eighteen of thirty patients were evaluable for eGFR at 2-years. Non-inferiority was not established based on a mean reduction in eGFR between baseline and 2 years of -8.7 mL/min/1.73m 2 (95% one-sided CI -14.1, ∞; p=0.71). Renal function decline was significantly associated with time, increasing age, baseline CKD stage 3-4, and larger baseline tumor size on multivariable analysis. Local control was 96.7% at 2 years. Conclusions Kidney-directed SBRT results in modest clinical renal function loss up to 2-years following SBRT, based on evaluable patients in our study. Technical advances may further improve the therapeutic ratio.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.007 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".