Assessment of Quality of Life and Outcomes in Patients With Primary Renal Cell Carcinoma Treated With SBRT (AQuOS-II)
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|ClinicalTrials.gov Identifier: NCT05023265|
Recruitment Status : Not yet recruiting
First Posted : August 26, 2021
Last Update Posted : September 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Radiation: Stereotactic body radiotherapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients diagnosed with Inoperable Renal Cell Carcinoma|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||October 2021|
|Estimated Primary Completion Date :||December 2026|
|Estimated Study Completion Date :||December 2026|
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.
- Local Control at 2 years [ 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)
- Progression-free and Overall survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Dosimetric parameters [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023265
|Contact: Tiffany Tassopoulos||416-480-6100 ext email@example.com|
|Contact: Kerri Durrant||416-480-6100 ext firstname.lastname@example.org|
|Principal Investigator:||William Chu, MD, FRCPC||Sunnybrook Health Sciences Center|