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

Phase 2

Active, not recruiting

• Conditions: Renal cell carcinoma with a single lesion within a kidney; Primary kidney tumour intact and no more than 5 documented metastases; Cancer - Kidney

• Registration Number: ACTRN12615001181594
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-03
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 71

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the activity and efficacy of the technique (composite outcome)[Freedom from local progression assessed by RECIST criteria at 12 mths.]

Secondary Outcome Measures

Name	Time	Method
Tolerability of SABR<br><br>[Assessed as cummulative incidents of severy toxicity by CTCAE v4 from date of treatment commencement until end of study];Estimate survival after SABR<br><br>[Assessed by clinical assessment at 24 mths post treatment];Estimate the distant failure rate after SABR<br>[Distant failure assessed by CT scan and clinical assessment<br>24 mths post treatment];Describe renal function change after SABR[Assessed by serum creatine and eGFR using a Cockroft Gault method<br> 1 year post treatment and 2 years post treatment]