Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney

Renal Cell Carcinoma Clinical Trial

— FASTRACK II  

Official title:

Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02613819
• Other study ID #: TROG 15.03
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cell Carcinoma

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