Clinical trial NCT05023265: Assessment of Quality of Life and Outcomes in Patients With Primary Renal Cell Carcinoma Treated With SBRT
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Juravinski Cancer Center
name: St. Joseph's Healthcare Hamilton
name: The Ottawa Hospital
name: Health Sciences North
name: Grand River Regional Cancer Centre
name: British Columbia Cancer Agency
First posted: 2021-08-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients diagnosed with Inoperable Renal Cell Carcinoma
Primary purpose: TREATMENT

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).

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.

Eligibility 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)
* 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

Primary outcomes:
measure: Local Control at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free and Overall survival
timeFrame: week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36
measure: Quality of life of Participants
timeFrame: Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36
measure: Health utilities
timeFrame: Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36
measure: Late treatment-related toxicities
timeFrame: week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36
Other outcomes:
measure: Dosimetric parameters
timeFrame: Baseline, Day 3, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36
measure: Anatomic Parameters
timeFrame: Baseline and months: 3,6,12,18,24 and 36
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Center
name: William Chu, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: