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

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ClinicalTrials.gov Identifier: NCT05023265
Recruitment Status : Not yet recruiting
First Posted : August 26, 2021
Last Update Posted : September 24, 2021
Sponsor:
Collaborators:
Juravinski Cancer Center
St. Joseph's Healthcare Hamilton
The Ottawa Hospital
Health Sciences North
Grand River Regional Cancer Centre
British Columbia Cancer Agency
Information provided by (Responsible Party):
Dr. William Chu, Sunnybrook Health Sciences Centre

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).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Radiation: Stereotactic body radiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients diagnosed with Inoperable Renal Cell Carcinoma
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026


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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Progression-free and Overall survival [ Time Frame: week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36 ]
    Will be assessed from treatment completion until the date of first progression or date of death from any cause, whichever comes first.

  2. Quality of life of Participants [ Time Frame: Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36 ]
    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.

  3. Health utilities [ Time Frame: Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36 ]
    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.

  4. Late treatment-related toxicities [ Time Frame: week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36 ]
    Incidence of late treatment related toxicities; assessment made based on the National Cancer Institute Common Toxicity Criteria Adverse Events (NCI CTCAE), version 4.


Other Outcome Measures:
  1. Dosimetric parameters [ Time Frame: Baseline, Day 3, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36 ]
    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 and 36 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023265


Contacts
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Contact: Tiffany Tassopoulos 416-480-6100 ext 88144 tiffany.tassopoulos@sunnybrook.ca
Contact: Kerri Durrant 416-480-6100 ext 89518 keri.durrant@sunnybrook.ca

Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Juravinski Cancer Center
St. Joseph's Healthcare Hamilton
The Ottawa Hospital
Health Sciences North
Grand River Regional Cancer Centre
British Columbia Cancer Agency
Investigators
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Principal Investigator: William Chu, MD, FRCPC Sunnybrook Health Sciences Center
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Responsible Party: Dr. William Chu, Assistant Professor, Dept of Radiation Oncology Sunnybrook Odette Cancer Centre, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT05023265    
Other Study ID Numbers: 3641
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases