Table 6:
Prospective interventional clinical trials evaluating the oncologic outcomes of SBRT and similar radiotherapy for the treatment of localized renal cell carcinoma.
| Study | Status | Experimental design | Intervention | Patient population | Patient enrollment | Outcomes | Follow-up | Conclusions |
|---|---|---|---|---|---|---|---|---|
| FASTRACK NCT01676428 | Complete | Phase I Single-arm Interventional trial |
SBRT | T1a–T2a RCC and Medically inoperable or High risk for surgery or Decline surgery |
Final Enrollment = 37 | AE LPFS DPFS OS |
Median = 24 months | Grades 1 & 2 toxicity = 78% Grade 3-4 toxicity = 3% Grades 4 & 5 toxicity = 0% 2-yr LPFS = 100% 2-yr DPFS = 89% 2-yr OS = 92% |
| FASTRACK II NCT02613819 | Active, not recruiting | Phase II Single-arm Interventional trial |
SBRT | Biopsy-confirmed RCC ≤ 8 cm and Medically inoperable or High risk or Decline surgery |
Current Enrollment = 71 | PFS | Ongoing | Ongoing |
| AQuOS-RCC NCT03108703 | Active, not recruiting | Phase I Single-arm Interventional trial |
SBRT | Lesion ≥ 2.5 cm or Recurrent lesion following local ablative therapy | Enrollment Goal = 30 | QOL LC PFS OS AE |
Ongoing | Ongoing |
| AQuOS-II NCT05023265 | Not yet recruiting | Phase II Single-arm Interventional trial |
SBRT | Primary lesion 3–20 cm and Medically inoperable or Decline surgery | Enrollment Goal = 46 | LC PFS OS QOL AE |
Ongoing | Ongoing |
| NCT01890590 | Recruiting | Phase II Single-arm Interventional trial |
Cyberknife | Stage I RCC | Enrollment Goal = 46 | LPFS QOLAE |
Ongoing | Ongoing |
| NCT03811665 | Active, not recruiting | Phase I Two-arm Interventional trial |
SBRT vs RFA | Biopsy-confirmed T1a RCC | Enrollment Goal = 24 | Treatment failure OSDFSRFS |
Ongoing | Ongoing |
| NCT04115254 | Recruiting | Phase I-II Parallel arms Interventional trial |
SMART | Confirmed malignancy and Tumor ≤ 7 cm | Enrollment Goal = 1000 | Delivery success Tumor visualization Plan creation Tumor control |
Ongoing | Ongoing |
| NCT02141919 | Active, not recruiting | Phase II Single-arm Interventional trial |
SBRT | Biopsy-proven RCC (including oncocytoma) and Tumor ≤ 5 cm |
Current Enrollment = 16 | Tumor growth AE Renal function PFS |
Ongoing | Ongoing |
AE, adverse events; DFS, disease-free survival; DPFS, disease progression–free survival; LC, local control; LPFS, local progression–free survival;OS, overall survival; PFS, progression-free survival; QOL, quality of life; RCC, renal cell carcinoma; RFA, radiofrequency ablation; RFS, recurrence-free survival; SBRT, stereotactic body radiotherapy; SMART, stereotactic magnetic resonance–guided radiation therapy.