None listed
Conditions
Brief summary
This study aims to investigate the side effects, safety, and effectiveness of stereotactic hypofractionated body radiosurgery for oligometastatic renal cell tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have histologically or cytologically confirmed renal cell carcinoma and 1 to 3 extracranial metastases (with no prior systemic targeted therapy) or 4 to 6 extracranial metastases in patients currently on systemic targeted therapy AND no more than 1 to 3 progressing metastases. Study details Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. SABR treatment appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, spine, liver and kidney. We aim to test the ability of this new technique to control cancers that have spread beyond the kidney to other organs or to the bones. This study will involve discussing your medical history and progress of your renal cell tumour with the doctor. A whole body bone scan and CT scan of the chest, abdomen and pelvis will be performed to confirm the location and number of secondary deposits of the tumour prior to treatment and at follow up visits. In addition to the bone and CT scans, an additional scan called a diffusion and perfusion MRI will be used before treatment and 3 months after treatment to investigate the changes in cancer blood flow before and after treatment. Up to three sessions of SABR treatment will be performed, depending on the location of your secondary cancer deposits. As part of the study, blood samples will be taken before and after treatment at 5 timepoints over a period of approximately 3-4 months. Questionnaires looking at quality of life and pain will be completed before treatment, and at each follow up visit. Follow up visits will be performed at approximately 1 month, and every 3 months until 2 years after the radiotherapy treatment. This is the first step of the research, and is a ‘pilot’ study. If the technique is shown to be both feasible and tolerable for this pilot study of 30 patients, we would then look at expanding this study.
Interventions
Stereotactic hypofractionated body radiosurgery (SABR).
Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy and uses a dose of radiation delivered in 1-3 treatments that is much higher than standard radiotherapy dosages. The recommended dose fractionation for this study is site-specific, and ranges from 18Gy/1Fx to 45Gy/3Fx. The total dose of radiation may be 5-10 times higher than standard radiotherapy doses. Generally, SABR tre
Stereotactic hypofractionated body radiosurgery (SABR). Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy and uses a dose of radiation delivered in 1-3 treatments that is much higher than standard radiotherapy dosages. The recommended dose fractionation for this study is site-specific, and ranges from 18Gy/1Fx to 45Gy/3Fx. The total dose of radiation may be 5-10 times higher than standard radiotherapy doses. Generally, SABR treatment is given in a single 60 minute session, however, if more than one session of SABR treatment is required, this will be done on non-consecutive days within 14 days.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged 18 years or older - Histological or cytologically confirmed renal cell carcinoma - Bone Scan or CT Scan evidence of 1 to 3 extracranial metastases in patients with no prior systemic targeted therapy -Bone Scan or CT Scan evidence of 4 to 6 extracranial metastases in patients currently on systemic targeted therapy AND no more than 1 to 3 progressing metastases - An ECOG performance status score of 2 or less - Life expectancy greater than 9 months - Available for follow up
Exclusion criteria
- Previous high dose radiotherapy (BED > 20Gy) to the area to be treated - Intracranial metastases not controlled by previous surgery or stereotactic radiotherapy - Chemotherapy within +/- 3 weeks of SABR - Systemic targeted agents within +/- 7 days of SABR - Evidence of Spinal Cord Compression - Spinal Instability Neoplastic Score >= 7 unless case has been reviewed by a neurosurgical service and considered stable - Long bone Mirels score >= 7 unless reviewed by an orthopaedic service and considered stable
Outcome results
None listed