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Renal Cell CarcinomaPhase 2FASTRACK IINCT02613819

Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney

A Phase 2 study testing SABR in people with Renal Cell Carcinoma, run by Trans Tasman Radiation Oncology Group at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
SABR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteAustralia
Study dates
Jul 2016to 24 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3000

Other trials in Australia

About this study

Official title: 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.

Read the 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).

Being tested
SABR
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SABRRadiation

    Also called Stereotactic Ablative Body Radiotherapy

    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.

Study groups in NCT02613819
Study groupRoleWhat they receive
Stereotactic Ablative Body RadiotherapyExperimentalStereotactic 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
Receives: Radiation: SABR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria

    Responsive Evaluation Criteria in Solid Tumors (RECIST)

    Measured: 12mths post treatment

Secondary outcomes (5)

  1. Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4

    Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: 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

  2. Estimated Survival after SABR assessed by clinincal assessment

    Stereotactic Ablative Radiotherapy (SABR)

    Measured: assessed up to 60 months

  3. Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment

    Measured: 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

    Calculated Glomular Filtration Rate (GFR)

    Measured: Baseline, 12mths post treatment, and 24 mths post treatment

  5. Renal Function Change after SABR assessed by using eGFR

    Estimated Glomular Filtration Rate (eGFR)

    Measured: Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2015 (estimated)
  2. Study startJul 2016
  3. Primary completion24 Nov 2025
  4. Study completion24 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02613819
Sponsor's protocol ID
TROG 15.03
Acronym
FASTRACK II
Status last verified
Sep 2026
First submitted
4 Nov 2015
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Siva S, Ali M, Hardcastle N, Kron T, Higgs B, Foroudi F, Ruben J, Appu S, Martin J, Sridharan S, Montgomery R, Davey R, Lin C, Shaw M, Chander S, Sidhom M, Vanneste BGL, Murphy DG, Lawrentschuk N, Pryor D, Wood S, Moon D, Bressel M. Ultra-hypofractionated stereotactic ablative body radiotherapy for primary renal cell carcinoma: 5-year outcomes from a pooled analysis of the FASTRACK trials. Lancet Oncol. 2026 Jun;27(6):721-728. doi: 10.1016/S1470-2045(26)00170-1. Epub 2026 May 17.

    PubMed 42144019

  • Siva S, Pryor D, Martin J, Hardcastle N, Moon D, Kron T, Higgs B, Foroudi F, Ruben J, Sridharan S, Montgomery R, Davey R, Lin C, Shaw M, Lawrentschuk N, Appu S, Vanneste BGL, Hofman MS, Murphy DG, De Abreu Lourenco R, Mancuso P, Brook NR, Raman A, Wong LM, Sidhom M, Wood S, Ali M, Bressel M. Long-term outcomes of stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a multicentre, non-randomised, phase 2 study. Lancet Oncol. 2026 Jun;27(6):711-720. doi: 10.1016/S1470-2045(26)00091-4. Epub 2026 May 17.

    PubMed 42144018

  • Siva S, Bressel M, Sidhom M, Sridharan S, Vanneste BGL, Davey R, Montgomery R, Ruben J, Foroudi F, Higgs B, Lin C, Raman A, Hardcastle N, Hofman MS, De Abreu Lourenco R, Shaw M, Mancuso P, Moon D, Wong LM, Lawrentschuk N, Wood S, Brook NR, Kron T, Martin J, Pryor D; FASTRACK II Investigator Group. Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial. Lancet Oncol. 2024 Mar;25(3):308-316. doi: 10.1016/S1470-2045(24)00020-2.

    PubMed 38423047

  • Siva S, Chesson B, Bressel M, Pryor D, Higgs B, Reynolds HM, Hardcastle N, Montgomery R, Vanneste B, Khoo V, Ruben J, Lau E, Hofman MS, De Abreu Lourenco R, Sridharan S, Brook NR, Martin J, Lawrentschuk N, Kron T, Foroudi F. TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II. BMC Cancer. 2018 Oct 23;18(1):1030. doi: 10.1186/s12885-018-4916-2.

    PubMed 30352550

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SABR in people with Renal Cell Carcinoma, run by Trans Tasman Radiation Oncology Group at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria (time frame: 12mths post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02613819, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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