Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney
NCT ID: NCT02613819
Last Updated: 2022-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
71 participants
INTERVENTIONAL
2016-07-31
2025-04-30
Brief Summary
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Detailed Description
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* 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).
Conditions
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Study Design
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NA
SINGLE_GROUP
* Fraction schedule 1: 26Gy in 1 fraction, for tumours \< 4cm in size
* Fraction schedule 2: 42Gy in 3 fractions, for tumours \> 4cm in size
TREATMENT
NONE
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Trans Tasman Radiation Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Shankar Siva, A/Prof
Role: PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Centre, Australia
Locations
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Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Countries
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References
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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.
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.
Other Identifiers
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TROG 15.03
Identifier Type: -
Identifier Source: org_study_id
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