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

November 16, 2022 updated by: Trans Tasman Radiation Oncology Group

Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3000
        • Peter Maccallum Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Stereotactic Ablative Body Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12mths post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Estimated Survival after SABR assessed by clinincal assessment
Time Frame: assessed up to 60 months
Stereotactic Ablative Radiotherapy (SABR)
assessed up to 60 months
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
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
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)
Baseline, 12mths post treatment, and 24 mths post treatment
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)
Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trans Tasman Radiation Oncology Group

Investigators

  • Principal Investigator: Shankar Siva, A/Prof, Peter MacCallum Cancer Centre, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 22, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROG 15.03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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