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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02613819
Other study ID # TROG 15.03
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 2016
Est. completion date April 2025

Study information

Verified date November 2022
Source Trans Tasman Radiation Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 71
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Radiation:
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.

Locations

Country Name City State
Australia Peter MacCallum Cancer Centre East Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Trans Tasman Radiation Oncology Group

Country where clinical trial is conducted

Australia, 

Outcome

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