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

Overview

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.

The investigators will prospectively assess the efficacy, toxicity and impact on quality of life (QoL) of SBRT in the treatment of inoperable RCC

Interventions

• 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.

Primary outcome measures

• Local Control at 2 years [Time frame: 2 years]

Secondary outcome measures (4)

• Severity of late treatment-related toxicity [Time frame: 6-60 months]
• Incidence of late treatment-related toxicity [Time frame: 6-60 months post-SBRT]
• Quality of life score (e.g., EPIC-26 or other tool) [Time frame: Months 3, 6, 9, 12, 18, 24, 36, 48, and 60 post-SBRT]
• Late Toxicity [Time frame: Week 4-6 post-SBRT]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Sunnybrook Health Sciences — Toronto

Identifiers

NCT: NCT05023265 · 3641

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗