Renal Cell Carcinoma
Conditions
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).
Interventions
RADIATIONSABR
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.
Sponsors
Trans Tasman Radiation Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria | 12mths post treatment | Responsive Evaluation Criteria in Solid Tumors (RECIST) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4 | 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 | Common Terminology Criteria for Adverse Events (CTCAE) |
| Estimated Survival after SABR assessed by clinincal assessment | assessed up to 60 months | Stereotactic Ablative Radiotherapy (SABR) |
| Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment | 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 | — |
| Renal Function Change after SABR assessed by split renal function and GFR | Baseline, 12mths post treatment, and 24 mths post treatment | Calculated Glomular Filtration Rate (GFR) |
| Renal Function Change after SABR assessed by using eGFR | Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths | Estimated Glomular Filtration Rate (eGFR) |
Countries
Australia
Outcome results
None listed