Sunnybrook Health Sciences
Toronto, Ontario, Canada
Location status: Recruiting
Location contact
William Chu
CONTACT
NCT Number: NCT05023265
This is a multicenter, single arm phase II study of stereotactic body radiation therapy (SBRT) for patients with medically inoperable primary renal cell carcinoma (RCC).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, Canada
Location status: Recruiting
William Chu
CONTACT
Primary renal cell carcinoma (RCC) is a common malignancy in Canada. The current standard of care for fit patients with localized RCC is surgical resection of the kidney (nephrectomy). RCC, however, affects predominately an older population with a median age at diagnosis of 65 years. Surgery is often not an option for these patients due to existing co-morbidities, and in an increasing environment of shared decision making in healthcare, some patients decline surgical resection and seek less invasive alternatives.
Stereotactic body radiotherapy (SBRT) is a treatment approach that offers precise delivery of highly conformal radiotherapy to the tumour with minimal exposure to the surrounding normal tissues. SBRT is non-invasive and not limited by the size or location of kidney tumors like other ablative strategies. The worldwide experience of treating RCC with SBRT is growing and the results to date are promising. There is broader enthusiasm from both the radiation oncology and urology community to increase utilization of SBRT for RCC in non-surgical patients within the context of a well-designed prospective trial in Canada.
The investigators will prospectively assess the efficacy, toxicity and impact on quality of life (QoL) of SBRT in the treatment of inoperable RCC
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SBRT is a non-invasive treatment approach that delivers precise and highly conformal radiotherapy to the tumour with steep dose gradients that minimize exposure to the surrounding normal tissues.
Time frame: 2 years
Local control at 2 years defined as the absence of progression of disease of the treated primary kidney cancer using Responsive Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Time frame: 6-60 months
Maximum CTCAE grade recorded
Time frame: 6-60 months post-SBRT
Assessed using NCI CTCAE v4.0
Time frame: Months 3, 6, 9, 12, 18, 24, 36, 48, and 60 post-SBRT
Change from baseline
Time frame: Week 4-6 post-SBRT
Assessed using NCI CTCAE v4.0
Time frame: Baseline, Day 3, week 4-6 post-SBRT, and months: 3,6,9,12,18,24,36,48 and 60
Dosimetric parameters (i.e. amount of radiation) to organs at risk (stomach, duodenum, small bowel, large bowel, liver, and normal kidneys) will be collected prospectively for all patients for any correlation between the amount of radiation to specific organs and the presence of toxicities (e.g. stomach upset, nausea/vomiting, diarrhea).
Time frame: Baseline and months: 3,6,12,18,24,36,48 and 60 post SBRT
Size, volume and localisation of the kidney tumour relative to organs at risk (stomach, duodenum, liver, normal kidney) will be collected prospectively for all patients.
Contact information is provided by the study sponsor or research team.
Sunnybrook Health Sciences Centre
Other
Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiotherapy (SBRT) for Inoperable Renal Cell Carcinoma (RCC): A Multicenter Phase II Study
Acronym: AQuOS-II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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