SABR for Renal Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03747133|
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : April 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Renal Tumor||Radiation: Stereotactic Ablative Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Stereotactic Ablative Radiotherapy
Adult patients with Kidney mass (either primary or metastasis) amenable to SABR
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.
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: Joelle Helou, MD||416-946-4501 ext firstname.lastname@example.org|
|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: Joelle Helou, MD 416-946-4501 ext 4866 email@example.com|
|Principal Investigator: Joelle Helou, MD|
|Sub-Investigator: Andrew Bayley, MD|
|Principal Investigator:||Joelle Helou, MD||University Health Network--Princess Margaret Cancer Centre|