Clinical trial NCT02613819: Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney
Official title: Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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

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).

Eligibility 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

Primary outcomes:
measure: Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria
timeFrame: 12mths post treatment
Secondary outcomes:
measure: Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4
timeFrame: 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
measure: Estimated Survival after SABR assessed by clinincal assessment
timeFrame: assessed up to 60 months
measure: Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment
timeFrame: 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
measure: Renal Function Change after SABR assessed by split renal function and GFR
timeFrame: Baseline, 12mths post treatment, and 24 mths post treatment
measure: Renal Function Change after SABR assessed by using eGFR
timeFrame: Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Shankar Siva, A/Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.