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NCT Number: NCT05023265

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences

Toronto, Ontario, Canada

Location status: Recruiting

Location contact

William Chu

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stereotactic body radiotherapy

Radiation

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 outcomes

  1. 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)

Secondary outcomes

  1. Severity of late treatment-related toxicity

    Time frame: 6-60 months

    Maximum CTCAE grade recorded

  2. Incidence of late treatment-related toxicity

    Time frame: 6-60 months post-SBRT

    Assessed using NCI CTCAE v4.0

  3. 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

    Change from baseline

  4. Late Toxicity

    Time frame: Week 4-6 post-SBRT

    Assessed using NCI CTCAE v4.0

Other outcomes

  1. Dosimetric parameters

    Time frame: Baseline, Day 3, week 4-6 post-SBRT, and months: 3,6,9,12,18,24,36,48 and 60

    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).

  2. Anatomic Parameters

    Time frame: Baseline and months: 3,6,12,18,24,36,48 and 60 post SBRT

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chris Zehr

CONTACT

[email protected]

416-480-6100 ext. 88144

Kerri Durrant

CONTACT

[email protected]

416-480-6100 ext. 89518

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • British Columbia Cancer Agency
  • Durham Regional Cancer Centre
  • Grand River Regional Cancer Centre
  • Health Sciences North
  • Juravinski Cancer Center
  • London Health Sciences Centre

Registry information

Official study 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

Acronym: AQuOS-II

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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