TROG 15.03 / ANZUP 16.001 Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney - A Phase II Clinical Trial (FASTRACK II)
Trans Tasman Radiation Oncology Group (TROG Cancer Research)Dataset description
This dataset includes data for 71 trial participants (50 male, 21 female) with renal cell carcinoma, taking part in the single arm, phase II FASTRACK study. Participants were recruited at sites in 7 Australian sites and 1 international site (MAASTRO), and includes data from beginning of study through to 96 month follow up. The study commenced in Aug 2016 and conducted the last patient last visit in April 2025. Dataset includes Timepoints from baseline to 96 months follow-up, tumour imaging, disease progression and AEs. Cancer Australia demographic data, Postcode of home of address, Aboriginal or Torres Strait Islander status (or Ethnicity,) Culturally and Linguistically Diverse (CALD) status, Country of Birth and Main language other than English used as the principle means of communication. Radiotherapy quality assurance data collected includes 11 benchmarking reviews, 71 pre-RT plan review, 69 post-RT plan review, 16 MRI substudy scans (baseline, 3, 12 months), split renal function scans (baseline, 12, 24, 42, 60 months).Date Information
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12615001181594
Funding
Commercial sector/Industry, Varian Medical Systems
Scientific enquiries
Dr Shankar Siva
Brief Summary
This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers. 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 1. ECOGperformance of 0-2 inclusive. 2. Life expectancy > 9 months 3. Either medically inoperable, technically high risk for surgery or decline surgery. 4. Multidisciplinary decision for active treatment Study Detai .... Read more
Key Inclusion Criteria
1. Age > 18 years old 2. All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney 3. ECOG performance of 0-2 inclusive. 4. Life expectancy > 9 months 5. Either medically inoperable, technically high risk for surgery or decline surgery. 6. Multidisciplinary decision for active treatment
Key Exclusion Criteria
1. 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. 2. Previous high-dose radiotherapy to an overlapping region 3. Tumours of larger than 8cm is size
Can healthy volunteers participate?
No
Population
Sample Size 71
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Renal cell carcinoma with a single lesion within a kidney , Primary kidney tumour intact and no more than 5 documented metastases
Condition code Cancer
Intervention
Intervention code Treatment: Other , Treatment: Devices
Stereotactic Radiotherapy in two schedules depending on tumor size: Fraction schedule 1: 26Gy in 1 fraction, for tumours of less than or equal to 4cm in size Fraction schedule 2: 42Gy in 3 fractions, for tumours of greater than 4cm in size (i.e. 14Gy per fraction, given in 3 fractions over a max of 3 weeks, each fraction given on non consecutive days)
Comparison
Control group Uncontrolled
No control group
Outcomes
Outcome: To estimate the activity and efficacy of the technique (composite outcome)Timepoint: Freedom from local progression assessed by RECIST criteria at 12 mths.