A prospective randomized parallel-controlled pilot trial of stereotactic body radiation therapy versus radiofrequency ablation for the management of small renal masses.
Bibliographic record
Abstract
363 Background: The potential of ablative technologies as an alternative to surgery for the treatment of small renal masses (SRMs) ≤4cm is unclear. Our objective was to evaluate the feasibility and toxicity of stereotactic body radiation therapy (SBRT) and radiofrequency ablation (RFA) for SRMs in a prospective randomized pilot trial. Methods: Patients scheduled for renal cell carcinoma (RCC) treatment at a single academic center were approached for the pilot trial, with the aim of recruiting 24 patients. Participants were assigned 1:1 to SBRT or RFA. Imaging (CT or MRI) using a renal tumor protocol is completed at 3, 6, 9, and 12 months post-procedure. Biopsies were completed prior to the procedure and at 12 months. Multiple clinical parameters were collected. Follow-up visits will occur at 6 month intervals following the trial up to 5 years. SBRT included an initial simulation session and a single image-guided treatment session with a prescribed dose of 25 Gy. RFA was conducted by either percutaneous or laparoscopic access with 2 cycles of 8 minutes duration each upon reaching target temperature. Results: Beginning in December 2019, 24 patients were recruited and randomized (SBRT = 11; RFA = 13). Eleven had SBRT, 8 RFA, 3 have not yet had treatment, and 2 became ineligible. Median age for all patients was 67 (53,85) and 17 were male. A total of 17 patients had clear cell RCC, 6 had papillary RCC (type 1), and 1 had chromophobe RCC. All patients had T1a disease. Mean procedure length (minutes) for SBRT and RFA was 15.5±7.4 and 10.5±3.9, respectively. Two patients (both SBRT) had a 12-month biopsy showing no evidence of recurrence or metastases, while two patients (1 RFA, 1 SBRT) had a 9-month CT showing no recurrence. Data are pending for the remaining patients. An early grade 2 flare-up occurred in one SBRT patient. Conclusions: Recruitment and randomization of patients with SRMs in a SBRT vs. RFA prospective trial is feasible on a timeline that allows for regular follow-up and imaging. To date, both treatment modalities have been shown to have excellent short-term safety profiles.
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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 | 0.008 | 0.008 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.004 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.005 |
| Insufficient payload (model declined to judge) | 0.011 | 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".