A pilot study of Focal Ablative Stereotactic Radiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases.
A pilot study of the feasibility of performing Focal Ablative Stereotactic Radiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases.
Dr Shankar Siva
30 participants
May 21, 2012
Interventional
Conditions
Summary
Stereotactic body radiotherapy (SBRT) is an new form of cancer treatment involving highly precise radiotherapy. SBRT appears to be effective in controlling cancer in other sites in the body, including the lung and the liver. We aim to test the ability of this new technique to control cancers in the kidney. This is the first step of the research, and is a ‘pilot’ study. Who is it for? You may be eligible to join this study if you are aged greater than 18 years and have a radiological diagnosis or biopsy confirmed diagnosis of either renal cell carcinoma or solitary adrenal metastases. Trial Details If you participate in this study, you will have either a single session of stereotactic body radiotherapy (SBRT) or three sessions of SBRT, depending on how big your cancer is. In order to deliver this treatment, you will need to attend a ‘planning’ session where your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be physically delivered when it comes to the time of treatment. This session will take approximately 45 minutes. When the treatment starts, the total time required to deliver the treatment will be one hour. In addition to the visits required to plan and deliver the radiotherapy, blood samples will be taken as part of this research. These will be taken at the same time as blood is collected to assess your kidney function (which would be standard care). Therefore will not require any additional blood collection visits than would be routinely performed to treat your cancer. Both the kidney function blood sample (standard of care) and the research related blood sample will be taken a total of 3 times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. Follow-up will involve a visit at approximately 2.5 to 3 months, and then at 6 months, 9 months, and 12 months from treatment. If you have a primary kidney cancer (renal cell carcinoma), then in addition to the steps outlined above you will have a research related ‘Diffusion weighted-MRI’ scan performed a total of three times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. The Diffusion weighted-MRI scan is similar to a standard MRI scan, but is taken over a longer period of time. Each Diffusion weighted-MRI scan takes approximately 30 minutes. For those patients with adequate kidney function, you will also have a contrast injection at the time of the MRI, which will add an additional 10 minutes to the scan time. The MRI allows us to examine the blood flow into kidneys and the cancer. To assess the function of the kidney after the SBRT treatment, a ‘positron emission tomography’ (PET) scan will be taken at approximately the same timepoints as the perfusion scans; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. This will involve injection of a radioactive tracer and a subsequent scan which will take approximately 30 minutes to capture. This will require you attending the PET Centre for a period of 2 or 3 hours. Participation in this study will involve no extra cost due to either having these scans or the treatment.
Eligibility
Inclusion Criteria7
- Age > 18 years old
- All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:
- (a) 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
- (b) Cohort 2: solitary adrenal metastases with with primary disease controlled
- ECOG performance of 0-2 inclusive.
- Either medically inoperable, technically high risk for surgery or decline surgery.
- Informed consent.
Exclusion Criteria3
- Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Targeted agents (such as sunitinib) are allowable.
- Any patient who is currently pregnant or breastfeeding.
- Previous high-dose radiotherapy to upper abdomen
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Interventions
For lesions less than 5cm - Image guided single fraction radiosurgery to26Gy prescribed to covering isodose. This is a single session of radiotherapy taking approximately 1 hour. For lesions greater than or equal to 5cm - Image guided fractionated Stereotactic Body Radiotherapy (SBRT) to 45Gy in 3 fractions prescribed to covering isodose. This is 3 sessions of radiotherapy, delivered at least 48 hours apart, taking approximately 1 hour per session. Prior to radiotherapy commencing, both treatment groups require a planning visit which will last approximately 1 hour, as well as a further 'mock-up' visit which will last approximately 45 minutes.
Locations(1)
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ACTRN12612000759897