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

Renal Cell Carcinoma Clinical Trial

— AQuOS-II  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05023265
• Other study ID #: 3641
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: December 2026

Study information

• Verified date: September 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: Tiffany Tassopoulos
• Phone: 416-480-6100
• Email: tiffany.tassopoulos[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	British Columbia Cancer Agency, Grand River Regional Cancer Centre, Health Sciences North, Juravinski Cancer Center, St. Joseph's Healthcare Hamilton, The Ottawa Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dosimetric parameters	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).	Baseline, Day 3, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36
Other	Anatomic Parameters	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.	Baseline and months: 3,6,12,18,24 and 36
Primary	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	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
Secondary	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
Secondary	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
Secondary	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