AQuOS-II: Assessment of Quality of Life and Outcomes in Patients With Primary Renal Cell Carcinoma Treated With SBRT
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
We will prospectively assess the efficacy, toxicity and impact on quality of life (QoL) of SBRT in the treatment of inoperable RCC.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SBRT for Medically Inoperable RCC 35-40 Gy in five fractions (7-8 Gy/day) |
Radiation: Stereotactic 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Progression-free and Overall survival [week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36]
Will be assessed from treatment completion until the date of first progression or date of death from any cause, whichever comes first.
- Quality of life of Participants [Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36]
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.
- Health utilities [Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36]
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.
- Late treatment-related toxicities [week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36]
Incidence of late treatment related toxicities; assessment made based on the National Cancer Institute Common Toxicity Criteria Adverse Events (NCI CTCAE), version 4.
Other Outcome Measures
- Dosimetric parameters [Baseline, Day 3, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36]
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).
- Anatomic Parameters [Baseline and months: 3,6,12,18,24 and 36]
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.
Eligibility Criteria
Criteria
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)
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Primary lesion >3 cm, or recurrent lesion following local ablative therapy
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Medically inoperable or patient who refuses surgery following assessment by experienced urologist, and discussed in a multidisciplinary setting
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ECOG 0-2
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Written informed consent
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Participants must be able to understand the English-language or with the aid of a translator
Exclusion Criteria:
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Primary Lesion >20cm
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Evidence of distant metastatic disease
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Previous abdominal RT in vicinity of kidney preventing definitive SBRT
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History of major radiosensitivity syndrome
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Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer)
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Currently pregnant or lactating
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
- Juravinski Cancer Center
- St. Joseph's Healthcare Hamilton
- The Ottawa Hospital
- Health Sciences North
- Grand River Regional Cancer Centre
- British Columbia Cancer Agency
Investigators
- Principal Investigator: William Chu, MD, FRCPC, Sunnybrook Health Sciences Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3641