Assessment of Quality of Life and Outcomes in Patients With Primary Renal Cell Carcinoma Treated With SBRT

Study Overview
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Brief Summary
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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
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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. We will prospectively assess the efficacy, toxicity and impact on quality of life (QoL) of SBRT in the treatment of inoperable RCC.

Official Title
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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

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Radiation: Stereotactic body radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients diagnosed with Inoperable Renal Cell Carcinoma
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT for Medically Inoperable RCC<br>35-40 Gy in five fractions (7-8 Gy/day) | Radiation: Stereotactic body radiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control at 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) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free and Overall survival | Will be assessed from treatment completion until the date of first progression or date of death from any cause, whichever comes first. | week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36 | 
| Quality of life of Participants | The Quality of Life will be measured using The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) in renal cell carcinoma patients and The EuroQol 5 Dimension 5 Level (EQ-5D-5L). Each question is scored from 1-4, 1 being the better outcome and 4 being the worst outcome. | Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36 | 
| Health utilities | Health utilities will be measured using The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) in renal cell carcinoma patients and The EuroQol 5 Dimension 5 Level (EQ-5D-5L). Each question is scored from 1-4, 1 being the better outcome and 4 being the worst outcome. | Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36 | 
| Late treatment-related toxicities | Incidence of late treatment related toxicities; assessment made based on the National Cancer Institute Common Toxicity Criteria Adverse Events (NCI CTCAE), version 4. | week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36 |