ACTRN12610000690055
Active, not recruiting
Phase 1
Pilot study of Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres (SIR-Spheres microspheres) in patients with Renal cell carcinoma.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Sirtex Technology Pty Ltd
- Enrollment
- 21
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be considered eligible for the study, patients must fulfil the following inclusion criteria:
- •(a) Willing, able and mentally competent to provide written informed consent.
- •(b) Histologically confirmed primary renal cell carcinoma of the kidney.
- •(c) Unequivocal and measurable MRI evidence of primary renal cell carcinoma that either:
- •1\) is not suitable for treatment by surgical resection, local ablation or other conventional techniques with curative intent; or 2\) does not require immediate treatment by surgical resection, local ablation or other conventional techniques with curative intent, at the time
- •of study entry.
- •(d) Metastatic disease other than untreated central nervous system (CNS) metastases is permitted.
- •(e) All imaging evidence used as part of the screening process must be less than 45 days old at the time of delivery of protocol SIRT therapy.
- •(f) Suitable for protocol therapy as determined by both the Medical Oncology and Surgical Urology Investigators.
- •(g) Other than radiotherapy, prior therapy for primary renal cell carcinoma is allowed, provided that such therapy was administered and completed at least 45 days prior to
Exclusion Criteria
- •Patients will be considered ineligible for the study for any of the following reasons:
- •(a) Previous radiotherapy delivered to the kidney or within a 5cm margin.
- •(b) Subsequent therapy planned to be administered within 60 days of the delivery of protocol SIRT therapy.
- •(c) Renal\-to\-lung shunt fraction that indicates potential exposure to the lung to an absorbed radiation dose of more than 25Gy.
- •(d) Inadequate renal function as defined by estimated GFR \<30 ml/min/1\.7m2\.
- •(e) Intercurrent disease that would render the patient unsuitable for treatment according to this protocol.
- •(f) Equivocal, immeasurable, or unevaluable primary renal cell carcinoma in the kidney.
- •(g) Pregnant or breast feeding.
Outcomes
Primary Outcomes
Not specified
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