Pilot study of Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres (SIR-Spheres microspheres) in patients with Renal cell carcinoma (STX0110).
- Conditions
- Renal Cell CarcinomaCancer - Kidney
- Registration Number
- ACTRN12610000690055
- Lead Sponsor
- Sirtex Technology Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 21
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
entry into this study.
(h) World Health Organisation (WHO) performance status 0 – 2.
(i) Adequate haematological and renal function as follows:
Haematological Neutrophils > 1.5 x 109/L
Platelets > 100 x 109/L
Renal Calculated glomerular filtration rate (GFR) > 30 ml/min/1.73m2
(j) Aged 18 years or older.
(k) Female patients must be postmenopausal, or surgically sterile, or if sexually active using
an acceptable method of contraception.
(l) Male patients must be surgically sterile or if sexually active and having a pre-menopausal
female partner must be using an acceptable method of contraception.
(m) Life expectancy of at least 3 months without any active treatment.
(n) Renal arterial anatomy suitable for implantation of SIR-Spheres microspheres, as assessed by visceral and renal angiogram.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and toxicity will be assessed using the National Cancer Institute Common Terminology Criteria (NCICTC) version 4.0.[30 post-SIRT]
- Secondary Outcome Measures
Name Time Method Tumour Response (Response will be calculated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria).[12 Months post-SIRT];Progression-free survival (PFS) is defined as the time interval between study entry and the<br>date of tumour progression. Tumour progression in the kidney is determined from serial 3 monthly magnetic resonance imaging (MRI) scans.[12 Months post-SIRT];Overall survival (OS) is defined as the time interval between the date of study entry and the date of<br>death.[12 months post-SIRT];Quality of life will be measured by using a renal cell carcinoma specific questionnaire<br>(Harding 2007) and will be assessed at baseline, 30 days post-SIRT and<br>then at 3 month intervals for the first 12 months post-SIRT.[12 months post-SIRT]