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Table 2 Participant Assessments

From: TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II

ASSESSMENTS Pre-Registrationa,b Post Treatmentc Post Progressionf
4 wks 3 mths 6 mths 9 mths 12 mths 18 mths 24 mths 33 mths 42 mths 51 mths 60 mths Annually thereafterd Progressione Annually
Informed Consent               
Informed consent for Health Economics datag               
CT (Thorax/Abdomen) h,i    h,i  
Split Renal Function Test
(DMSA SPECT/CT) and calculated GFR (Cr-51 EDTA) j
           j   
Whole body bone scan               
Clinical Consultation    
Eligibility confirmation               
Blood Testsk and eGFR l  
QLQ-C30 questionnaire m    m
Adverse Event Reporting  
Survival Status               
MRI Sub studyn
 Informed Consent               
 Multiparametric MRI               
  1. aTo be done within 8 weeks of registration
  2. bTreatment to commence within 6 weeks of registration
  3. cCalculated from the date of the last radiotherapy fraction given. Post treatment follow-up to continue until both local and distant progression has been recorded
  4. dAfter participant has both local and distant progression documented, annual survival status will be collected
  5. eTo be done at both local and distant progression
  6. fAfter participant has both local and distant progression documented, annual survival status will be collected until study closure
  7. gAustralian Participants only for consent to access outpatient medical and pharmaceutical services via the MBS and PBS
  8. hWith or without contrast
  9. iCT to include pelvis at pre-registration & progression scans. The target lesion size determined from the pre-registration scan CT will dictate the fractionation schedule to be prescribed
  10. j- Where split function cannot be performed by DMSA SPECT/CT, a MAG-3 study should be performed
  11. - Calculated GFR through Cr-51 EDTA measurement or equivalent should be performed at this time point whenever possible, if this study is available
  12. - This should be the same study for all investigations time points
  13. - After the 60 month post follow-up visit, these are to be performed biennially until study completion
  14. kBlood test include - full blood count (FBE), serum urea and electrolytes (UEC’s), c-reactive protein (CRP) and estimated glomerular filtration rate (eGFR)
  15. lDetermined by the CKD-EPI equation
  16. mQLQ-C30 questionnaire is to be completed post progression until participant reached 5 years post treatment
  17. nParticipating sites only