SABR for Renal Tumors

NCT ID: NCT03747133

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2027-11-30

Brief Summary

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.

Conditions

Renal Tumor

Study Design

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

Study Groups

Stereotactic Ablative Radiotherapy

Adult patients with Kidney mass (either primary or metastasis) amenable to SABR

Group Type: EXPERIMENTAL

Stereotactic Ablative Radiotherapy

Intervention Type: RADIATION

Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.

Interventions

Stereotactic Ablative Radiotherapy

Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm
• Histological or radiological diagnosis of renal tumor
• Inoperable: High risk for surgery or declined surgery
• ECOG performance status of 0-3

Exclusion Criteria

• ≥5 active metastases
• Sysstemic therapy (except endocrine therapy) wthin 6 days prior to SABR
• Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney
• Patients with end stage renal failure > 4(KDOQI guidelines)
• Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis

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

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew McPartlin, MD

Role: PRINCIPAL_INVESTIGATOR

The Princess Margaret Cancer Foundation

Locations

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Site Status: NOT_YET_RECRUITING

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Andrew McPartlin, MD

Role: CONTACT

andrew.mcpartlin@rmp.uhn.ca

416-946-4501 ext. 4855

Facility Contacts

Andrew McPartlin, MD

Role: primary

andrew.mcpartlin@rmp.uhn.ca

416-946-4501 ext. 4855

Other Identifiers

18-5481

Identifier Type: -

Identifier Source: org_study_id