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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