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

Siva, Shankar; Chesson, Brent; Bressel, Mathias; Pryor, David; Higgs, Braden; Reynolds, Hayley M.; Hardcastle, Nicholas; Montgomery, Rebecca; Vanneste, Ben; Khoo, Vincent; Ruben, Jeremy; Lau, Eddie; Hofman, Michael S.; De Abreu Lourenco, Richard; Sridharan, Swetha; Brook, Nicholas R.; Martin, Jarad; Lawrentschuk, Nathan; Kron, Tomas; Foroudi, Farshad

doi:10.1186/s12885-018-4916-2

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-Registration^a,b	Post Treatment^c													Post Progression^f
ASSESSMENTS	Pre-Registration^a,b	4 wks	3 mths	6 mths	9 mths	12 mths	18 mths	24 mths	33 mths	42 mths	51 mths	60 mths	Annually thereafter^d	Progression^e	Annually
Informed Consent	✓
Informed consent for Health Economics data^g	✓
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 Tests^k and eGFR ^l	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
QLQ-C30 questionnaire ^m	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓			✓^m
Adverse Event Reporting	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Survival Status															✓
MRI Sub studyⁿ
Informed Consent	✓
Multiparametric MRI	✓		✓			✓

^aTo be done within 8 weeks of registration
^bTreatment to commence within 6 weeks of registration
^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
^dAfter participant has both local and distant progression documented, annual survival status will be collected
^eTo be done at both local and distant progression
^fAfter participant has both local and distant progression documented, annual survival status will be collected until study closure
^gAustralian Participants only for consent to access outpatient medical and pharmaceutical services via the MBS and PBS
^hWith or without contrast
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
^j- Where split function cannot be performed by DMSA SPECT/CT, a MAG-3 study should be performed
- Calculated GFR through Cr-51 EDTA measurement or equivalent should be performed at this time point whenever possible, if this study is available
- This should be the same study for all investigations time points
- After the 60 month post follow-up visit, these are to be performed biennially until study completion
^kBlood test include - full blood count (FBE), serum urea and electrolytes (UEC’s), c-reactive protein (CRP) and estimated glomerular filtration rate (eGFR)
^lDetermined by the CKD-EPI equation
^mQLQ-C30 questionnaire is to be completed post progression until participant reached 5 years post treatment
ⁿParticipating sites only

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ISSN: 1471-2407

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