Renal cell carcinoma
Conditions
Interventions
Stereotactic radiotherapy with a total dose of 42 Gy will be administered to the target lesion, followed by CT-guided cryoablation within 14 to 42 days after the completion of radiotherapy.
Sponsors
Matsui Yusuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older at the time of informed consent. 2. Written informed consent obtained voluntarily from the participant after receiving sufficient explanation of the study and demonstrating adequate understanding. 3. Presence of a centrally located renal cell carcinoma with a maximum diameter of 30-70 mm (Stage I). (Definition of centrally located renal cell carcinoma: tumor in contact with the renal sinus fat, hilar vessels, or urinary tract.) 4. Histologically confirmed clear cell renal cell carcinoma by biopsy. 5. Unamenable to surgical resection (partial or radical nephrectomy), or refusal of surgery by the patient. 6. ECOG Performance Status of 0 to 2.
Exclusion criteria
Exclusion criteria: 1. Presence of lymph node or distant metastasis. 2. Presence of multiple renal tumors. 3. Prior treatment (including systemic therapy) for the target lesion. 4. History of high-dose radiotherapy to overlapping anatomical regions (BED greater than 40 Gy, an alpha-to-beta ratio = 10). 5. Presence of untreated malignancy other than the target lesion. 6. Use of antiplatelet or anticoagulant medications with inability to discontinue them. 7. Platelet count less than 50,000/mcL or PT-INR greater than 1.5. 8. Inability to identify a safe percutaneous route for cryoprobe insertion, despite all available adjunctive techniques, such as adjustment of the patient's position. 9. Inability to safely perform radiotherapy due to the target lesion's contact with critical organs, including the gastrointestinal tract. 10. History of severe allergic reaction to iodinated contrast agents. 11. Deemed ineligible for study participation by the investigators for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-related adverse events (AEs) occurring within 3 months after treatment: AEs will be classified into three categories; those attributable to stereotactic radiotherapy, those attributable to cryoablation, and those for which attribution to either treatment cannot be determined. The severity of adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with events of Grade 3 or higher considered serious adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All adverse events occurring within 3 months after treatment 2. Renal function changes within 3 months after treatment: Renal function will be assessed using serum creatinine levels and eGFR. 3. Technical success of the treatment: Technical success is defined as completion of the treatment as planned, with the target lesion fully encompassed within the treatment zone of cryoablation (i.e., within the ice ball visualized as a low-attenuation area on intra-procedural CT). 4. Technical efficacy within 3 months after treatment: Technical efficacy will be evaluated based on the presence or absence of local tumor progression on CT or MRI performed 3 months after treatment. Nodular contrast enhancement within the treatment zone will be interpreted as local tumor progression. | — |
Contacts
Public ContactYusuke Matsui
Okayama University Hospital
Outcome results
None listed