SABR for Renal Tumors
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ClinicalTrials.gov Identifier: NCT03747133 |
Recruitment Status :
Recruiting
First Posted : November 20, 2018
Last Update Posted : October 18, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Tumor | Radiation: Stereotactic Ablative Radiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors |
Actual Study Start Date : | November 1, 2018 |
Estimated Primary Completion Date : | November 2023 |
Estimated Study Completion Date : | November 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Stereotactic Ablative Radiotherapy
Adult patients with Kidney mass (either primary or metastasis) amenable to SABR
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Radiation: Stereotactic Ablative Radiotherapy
Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions. |
- To evaluate the radiation induced renal impairments in patients receiving SABR. [ Time Frame: 2 years ]The prevalence of nephron toxicity in patients treated with SABR, measured by the change in Glomerular Filtration Rate (GFR) every 4 months over 2 years.
- Chronic Kidney Disease Stage Progression [ Time Frame: 2 years ]Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines
- 2-year Local recurrence rate [ Time Frame: 2 years ]2 year local recurrence rate of kidney tumors treated with SABR, measured by assessing the change of irradiated kidney function on functional imaging.
- Patient Reported Outcomes [ Time Frame: 2 years ]The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire.
- Incidence of acute and late toxicities [ Time Frame: 2 years ]The incidence of acute (≤3 months) and late complication of interest (GI or GU complications, high blood pressure and adrenal insufficiency) as assessed by CTCAE version 5.0.

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

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): NCT03747133
Contact: Rachel Glicksman, MD | 416-946-4501 ext 2853 | rachel.glicksman@rmp.uhn.ca |
Canada, Ontario | |
Royal Victoria Regional Health Centre | Not yet recruiting |
Barrie, Ontario, Canada, L4M 6M2 | |
University Health Network - Princess Margaret Cancer Centre | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Rachel Glicksman, MD 416-946-4501 ext 2853 rachel.glicksman@rmp.uhn.ca | |
Principal Investigator: Rachel Glicksman, MD | |
Sub-Investigator: Andrew Bayley, MD |
Principal Investigator: | Rachel Glicksman, MD | The Princess Margaret Cancer Foundation |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT03747133 |
Other Study ID Numbers: |
18-5481 |
First Posted: | November 20, 2018 Key Record Dates |
Last Update Posted: | October 18, 2022 |
Last Verified: | October 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stereotactic Body Radiation Therapy SABR Radiation Therapy Renal Cell Carcinoma RCC |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Kidney Diseases Urologic Diseases |