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

NCT ID: NCT05023265

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2026-12-31

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT for Medically Inoperable RCC

35-40 Gy in five fractions (7-8 Gy/day)

Group Type: EXPERIMENTAL

Stereotactic body radiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juravinski Cancer Center

OTHER

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: collaborator

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

Health Sciences North

OTHER

Sponsor Role: collaborator

Grand River Regional Cancer Centre

OTHER

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. William Chu

Assistant Professor, Dept of Radiation Oncology Sunnybrook Odette Cancer Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Chu, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center

Central Contacts

Tiffany Tassopoulos

Role: CONTACT

tiffany.tassopoulos@sunnybrook.ca

416-480-6100 ext. 88144

Kerri Durrant

Role: CONTACT

keri.durrant@sunnybrook.ca

416-480-6100 ext. 89518

Other Identifiers

3641

Identifier Type: -

Identifier Source: org_study_id