Renal Cell Carcinoma
Conditions
Brief summary
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).
Detailed description
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
Interventions
RADIATIONStereotactic body radiotherapy
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.
Sponsors
Sunnybrook Health Sciences Centre
Juravinski Cancer Center
Health Sciences North
Grand River Regional Cancer Centre
British Columbia Cancer Agency
London Health Sciences Centre
Durham Regional Cancer Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients diagnosed with Inoperable Renal Cell Carcinoma
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years old * Newly diagnosed RCC by biopsy (preferred) or radiologic evidence of growth on surveillance over two consecutive assessments (6-12 months) * Primary lesion \>3 cm, or recurrent lesion following local ablative therapy * Medically inoperable or patient who refuses surgery following assessment by experienced urologist, and discussed in a multidisciplinary setting * ECOG 0-2 * Written informed consent * Participants must be able to understand the English-language or with the aid of a translator
Exclusion criteria
* Primary Lesion \>20cm * Evidence of distant metastatic disease * Previous abdominal RT in vicinity of kidney preventing definitive SBRT * History of major radiosensitivity syndrome * Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer) * Currently pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Control at 2 years | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of late treatment-related toxicity | 6-60 months | Maximum CTCAE grade recorded |
| Incidence of late treatment-related toxicity | 6-60 months post-SBRT | Assessed using NCI CTCAE v4.0 |
| Quality of life score (e.g., EPIC-26 or other tool) | Months 3, 6, 9, 12, 18, 24, 36, 48, and 60 post-SBRT | Change from baseline |
| Late Toxicity | Week 4-6 post-SBRT | Assessed using NCI CTCAE v4.0 |
Countries
Canada
Contacts
CONTACTChris Zehr
CONTACTKerri Durrant
PRINCIPAL_INVESTIGATORWilliam Chu, MD, FRCPC
Sunnybrook Health Sciences Center
Outcome results
None listed