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

Primary Purpose

Renal Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
SABR
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peter MacCallum Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Ablative Body Radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria
Responsive Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures

Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4
Common Terminology Criteria for Adverse Events (CTCAE)
Estimated Survival after SABR assessed by clinincal assessment
Stereotactic Ablative Radiotherapy (SABR)
Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment
Renal Function Change after SABR assessed by split renal function and GFR
Calculated Glomular Filtration Rate (GFR)
Renal Function Change after SABR assessed by using eGFR
Estimated Glomular Filtration Rate (eGFR)

Full Information

First Posted
November 4, 2015
Last Updated
November 16, 2022
Sponsor
Trans Tasman Radiation Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02613819
Brief Title
Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney
Acronym
FASTRACK II
Official Title
Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Ablative Body Radiotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
SABR
Other Intervention Name(s)
Stereotactic Ablative Body Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria
Description
Responsive Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
12mths post treatment
Secondary Outcome Measure Information:
Title
Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4
Description
Common Terminology Criteria for Adverse Events (CTCAE)
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
Title
Estimated Survival after SABR assessed by clinincal assessment
Description
Stereotactic Ablative Radiotherapy (SABR)
Time Frame
assessed up to 60 months
Title
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
Title
Renal Function Change after SABR assessed by split renal function and GFR
Description
Calculated Glomular Filtration Rate (GFR)
Time Frame
Baseline, 12mths post treatment, and 24 mths post treatment
Title
Renal Function Change after SABR assessed by using eGFR
Description
Estimated Glomular Filtration Rate (eGFR)
Time Frame
Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shankar Siva, A/Prof
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30352550
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.
Results Reference
derived

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Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney

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