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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 : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Tumor Radiation: Stereotactic Ablative Radiotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 2020
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT03747133


Contacts
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Contact: Joelle Helou, MD 416-946-4501 ext 4866 joelle.helou@rmp.uhn.ca

Locations
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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: Joelle Helou, MD    416-946-4501 ext 4866    joelle.helou@rmp.uhn.ca   
Principal Investigator: Joelle Helou, MD         
Sub-Investigator: Andrew Bayley, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Joelle Helou, MD University Health Network--Princess Margaret Cancer Centre
More Information
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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: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Stereotactic Body Radiation Therapy
SABR
Radiation Therapy
Renal Cell Carcinoma
RCC
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Kidney Diseases
Urologic Diseases