Clinical trial · Interventional
A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases
- 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 "proof of concept" study, to assess the feasibility of introducing a novel high-precision radiotherapy technique called "stereotactic radiosurgery" (SRS) or "stereotactic body radiotherapy" (SBRT) for the treatment of kidney cancers in Australia. This study aims to invite 20 patients with renal cell carcinoma and 10 patients with isolated adrenal metastases from non-small cell carcinoma who are either medically inoperable, high risk for surgery, or decline surgery to participate. In cohort of patients with renal cell carcinoma, both patients with primary disease only, and those patients who have limited metastases (≤5) will be eligible. Besides technical feasibility of delivering this treatment, this study will be to assess efficacy, toxicity and tumour response using a novel imaging biomarker called diffusion weighted-MRI.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- The interventional treatment will be prescribed as a 2-tiered dose scheduled dependant of target size. For lesions \<5cm, a single fraction of 26 Gy will be prescribed. For lesions ≥5cm a fractionated course of 15Gy by 3 fractions will be prescribed, delivered at least 48 hours apart.
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- The number of patients who complete prescribed treatment.
- timeFrame
- After 24 months
- description
- This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s)
Secondary outcomes (3)
- measure
- Toxicity of SBRT in study patients measured using CTCAE V4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years old * All patients must have radiological diagnosis or biopsy confirmed diagnosis of either: 1. Cohort 1: renal cell carcinoma with a single lesion within kidney, or with primary kidney tumour intact and no more than 5 documented metastases, or 2. Cohort 2: single adrenal metastases with extra-adrenal disease controlled * ECOG performance of 0-2 inclusive. * Either medically inoperable, technically high risk for surgery or decline surgery. * Informed consent. Exclusion Criteria: * Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy. * Previous high-dose radiotherapy to upper abdomen
References
Publications (2)
- DERIVEDSiva S, Ali M, Hardcastle N, Kron T, Higgs B, Foroudi F, Ruben J, Appu S, Martin J, Sridharan S, Montgomery R, Davey R, Lin C, Shaw M, Chander S, Sidhom M, Vanneste BGL, Murphy DG, Lawrentschuk N, Pryor D, Wood S, Moon D, Bressel M. Ultra-hypofractionated stereotactic ablative body radiotherapy for primary renal cell carcinoma: 5-year outcomes from a pooled analysis of the FASTRACK trials. Lancet Oncol. 2026 Jun;27(6):721-728. doi: 10.1016/S1470-2045(26)00170-1. Epub 2026 May 17. PMID 42144019
- DERIVEDPham D, Thompson A, Kron T, Foroudi F, Kolsky MS, Devereux T, Lim A, Siva S. Stereotactic ablative body radiation therapy for primary kidney cancer: a 3-dimensional conformal technique associated with low rates of early toxicity. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1061-8. doi: 10.1016/j.ijrobp.2014.07.043. Epub 2014 Oct 13. PMID 25442039