Assessment of Quality of Life and Outcomes in Patients With Primary Renal Cell Carcinoma Treated With SBRT (AQuOS-II)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Radiation: Stereotactic body radiotherapy

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 Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiffany Tassopoulos; Phone Number: 88144 416-480-6100; Email: tiffany.tassopoulos@sunnybrook.ca
• Study Contact Backup: Name: Kerri Durrant; Phone Number: 89518 416-480-6100; Email: keri.durrant@sunnybrook.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: St. Joseph's Healthcare Hamilton; The Ottawa Hospital; British Columbia Cancer Agency; Juravinski Cancer Center; Health Sciences North; Grand River Regional Cancer Centre
• Investigators: Principal Investigator: William Chu, MD, FRCPC, Sunnybrook Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: 3641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No