Clinical trial · Interventional
A Phase I Evaluating Integration of HypofractionatedStudy Renal Ablative Radiotherapy
A Phase I Study Evaluating the Integration of Hypofractionated Renal Ablative Radiotherapy in the Setting of Metastatic Renal Cell Carcinoma
NCT02264548CI-TRIAL-00064563completedPhase 1ClinicalTrials.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)
* evaluate the safety and toxicity profile of renal radio-ablation in the setting of metastatic renal cell carcinoma. * to assess renal function post radio-ablation * Primary and metastatic tumour response to radio-ablation
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 |
|---|---|---|---|
| Radio-Ablation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Radiation: Radio-Ablation
- interventionNames
- Radiation: Radio-Ablation
Primary outcomes (1)
- measure
- evaluate the safety/toxicity profile of renal radio-ablation in the setting of metastatic RCC
- timeFrame
- After 3 patients have been seen at the 4 week follow up visit,
- description
- toxicity will be assessed using CTCAE v3
Secondary outcomes (1)
- measure
- Renal Function post renal radio-ablation
- timeFrame
- 4,8,12 wk and every 6months x 5yr
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Eligibility Criteria * Patients must have histologically confirmed carcinoma of the kidney * Patients must be able to tolerate extended treatment time 30 minutes for MVCT and treatment delivery) for radiation on the tomotherapy unit * Patients must have confirmed metastatic disease, nodal or locally advanced disease either by biopsy or imaging * Informed consent performed and documented * Patients must have one of a) unresectable local disease, b) be medically inoperable, or c) chosen against having a local surgical treatment * Age ≥ 18 * Patients previously received any targeted therapy or immunotherapy for RCC, are also eligible. Patients must be off these agents for a minimum of 2 weeks prior to radiation therapy to be eligible Exclusion Criteria: * Patients without an adequate functioning contralateral kidney as seen on renal perfusion scan (\>40% of total renal flow) * Patients with poor baseline renal function, represented by a creatinine clearance \< 50 mL/minute based on the Cockcroft-Gault approximation method * Patients with a creatinine clearance \< 50 ml/minute are still eligible if the ipsilateral kidney has \<25% of the total renal flow on a renal perfusion scan. еCCr =140 - (Age) × Mass (in kilograms) × constant Serum creatinine ( in µmol/L) constant = male is 1.23, women is 1.04) * Previous abdominal radiotherapy * Bilateral RCC * Diagnosis of transitional cell carcinoma, squamous cell carcinoma, or a non epithelial cancer of the kidney * Diagnosis of any other malignancy in previous 5 years, excluding non-melanoma skin cancer -Known active malignancy other than RCC, excluding non-melanoma skin cancer * Estimated (by treating radiation oncologist) life expectancy of less than 8 weeks * Pregnant or breast-feeding women * Concurrent illness in addition to RCC that would make radiotherapy delivery unduly challenging, including but not limited to, severe congestive heart failure or other cardiorespiratory conditions, severe neuromuscular disorders, ongoing or active infections, and psychiatric illness * Medical conditions for which radiation is contraindicated, including but not limited to, scleroderma, systemic lupus erythematosus and ataxia teleangiectasia - Patients with excessive kidney motion on pre-planning 4D-CT scan that would prevent safe delivery of radiotherapy with gated or non-gated techniques * Patients taking concurrent medication that can interfere with the safe delivery of radiation (e.g. radiosensitizers) * Urology opinion recommends partial nephrectomy as cytoreductive atment --Expected TKI therapy to be initiated during initial 2 weeks completion of radiotherapy.
References
Publications (2)
- DERIVEDCorrea RJM, Ahmad B, Warner A, Johnson C, MacKenzie MJ, Pautler SE, Bauman GS, Rodrigues GB, Louie AV. A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma. Radiat Oncol. 2018 Mar 20;13(1):47. doi: 10.1186/s13014-018-0992-3. PMID 29558966
- DERIVEDCorrea RJM, Rodrigues GB, Chen H, Warner A, Ahmad B, Louie AV. Stereotactic Ablative Radiotherapy (SABR) for Large Renal Tumors: A Retrospective Case Series Evaluating Clinical Outcomes, Toxicity, and Technical Considerations. Am J Clin Oncol. 2018 Jun;41(6):568-575. doi: 10.1097/COC.0000000000000329. PMID 27635623