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Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney (FASTRACK II)

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ClinicalTrials.gov Identifier: NCT02613819
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)

Brief Summary:
This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Radiation: SABR Phase 2

Detailed Description:

Who is it for?

  • Age > 18 years old
  • All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
  • ECOGperformance of 0-2 inclusive.
  • Life expectancy > 9 months
  • Either medically inoperable, technically high risk for surgery or decline surgery.
  • Multidisciplinary decision for active treatment

Study Details:

Definitive external beam radiotherapy (EBRT) is often used to treat medically inoperable patients with cancers in many different organs, including the kidneys. However, renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated EBRT in the form of stereotactic radiotherapy has renewed interest in the management of renal cell carcinoma with radiotherapy. This study will be evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of cancers of the kidney.

Participants in this study will be allocated to receive either multi-fraction SABR (3 fractions over 2 weeks) or single fraction SABR (1 fraction only).

All participants will be assessed at regular intervals post treatment in order to estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.

The follow-up visits occur at 4 weeks and every 3 months in the 1st year post treatment, then every 6 months in the second year and then yearly until study closure (2 years after the last participant finishes study treatment).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Radiotherapy;

  • Fraction schedule 1: 26Gy in 1 fraction, for tumours < 4cm in size
  • Fraction schedule 2: 42Gy in 3 fractions, for tumours > 4cm in size
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)
Study Start Date : July 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stereotactic Ablative Body Radiotherapy

Stereotactic Ablative Body Radiotherapy (SABR)

Treatment schedule 1: 26 Gray (Gy) in 1 fraction, for tumours of less than or equal to 4cm in size.

Treatment schedule 2: 42 Gray (Gy) in 3 fractions, for tumours of greater than 4cm in size

Radiation: SABR
Renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated External beam radiation therapy (EBRT) in the form of stereotactic radiotherapy will be used in the management of renal cell carcinoma with radiotherapy.
Other Name: Stereotactic Ablative Body Radiotherapy




Primary Outcome Measures :
  1. Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria [ Time Frame: 12mths post treatment ]
    Responsive Evaluation Criteria in Solid Tumors (RECIST)


Secondary Outcome Measures :
  1. Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4 [ Time Frame: From date of treatment commencement until first documented progression or date of death from any cause, whichever came first, assessed from 4wks, 3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mth post treatment ]
    Common Terminology Criteria for Adverse Events (CTCAE)

  2. Estimated Survival after SABR assessed by clinincal assessment [ Time Frame: assessed up to 60 months ]
    Stereotactic Ablative Radiotherapy (SABR)

  3. Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed from 6 mths, 9 mths, 12 mths, 18mths, 33 mths, 42 mths, 51 mths, and 60 mths post treatment ]
  4. Renal Function Change after SABR assessed by split renal function and GFR [ Time Frame: Baseline, 12mths post treatment, and 24 mths post treatment ]
    Calculated Glomular Filtration Rate (GFR)

  5. Renal Function Change after SABR assessed by using eGFR [ Time Frame: Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths ]
    Estimated Glomular Filtration Rate (eGFR)



Information from the National Library of Medicine

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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:

  • Age > 18 years old
  • All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
  • Eastern Cooperative Oncology Group (ECOG) performance of 0-2 inclusive.
  • Life expectancy > 9 months
  • Either medically inoperable, technically high risk for surgery or decline surgery.
  • Multidisciplinary decision for active treatment

Exclusion Criteria:

  • Pre-treatment estimated glomerular filtration rate < 30 mls/min
  • Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy.
  • Previous high-dose radiotherapy to an overlapping region
  • Tumours of larger than 8cm is size

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): NCT02613819


Contacts
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Contact: Courtney Hill +61 02 401 43900 trog@trog.com.au

Locations
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Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia, 3000
Contact: Jenny Trinh    +61 3 8559 8482    Jenny.Trinh@petermac.org   
Principal Investigator: Shankar Siva         
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
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Principal Investigator: Shankar Siva, A/Prof Peter MacCallum Cancer Centre, Australia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT02613819     History of Changes
Other Study ID Numbers: TROG 15.03
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases