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Table 2 Schedule of Assessments

From: Protocol for the P3BEP trial (ANZUP 1302): an international randomised phase 3 trial of accelerated versus standard BEP chemotherapy for adult and paediatric male and female patients with intermediate and poor-risk metastatic germ cell tumours

Visit Baseline On treatment:
BEP chemotherapy
Cycles 1 to 4
End of BEP chemotherapy safety assessment (Initial response assessment) Final response assessment Follow-up until progression Follow-up after progression
Within 21 days prior to randomisation Day 1 of Cycle (or within 3 days) Day 8 and 15 of Cycle
(or within 3 days)
30–42 days after the last dose of study treatment 6 months from randomisation,
or after completion of all post-chemo surgery and other interventions
(± 1 month)
9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months from randomisation,
then annually
(± 1 month)
Every 6 months
(± 1 month)
Clinical assessment X X   X X X (until 60 months)  
Respiratory symptoms/signs X X X X    
Adverse Event   X   X    
Blood tests including tumour markers X X X X X X (until 60 months)  
CT imaging X    X X X (12, 24, 36, 60 months)  
Chest X-Ray X X   X    
Patient-Rated Measures   X   X X X (9, 12, 18 months)  
Translational blood and tissue Optional       
Patient Status X    X X X X