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Table 1 Study calendar

From: OLIGOPELVIS – GETUG P07: a multicentre phase II trial of combined salvage radiotherapy and hormone therapy in oligometastatic pelvic node relapses of prostate cancer

Visits

Inclusion

Treatment period

follow-up

Visits

Max 2 months prior to RT day 1

M1 1 month after end of RT

Before progression

After progression

Every 6 months during 2 years

Every 6 months until progression

Every 6 months until death

 Inclusion/exclusion criteria

X

     

 Signed consent form

X

     

 Inclusion (max 2 months prior to RT)

X

     

 FCH PET

X (a)

    

X (b)

 Physical examination with PS

X

X (d)

X

X

X

X

 Prior history, tumor characteristics

X

     

 Blood Pressure

X

X (d)

X

X

  

 Acute toxicity during ADT and RT (f)

 

X (d)

X

   

 Late toxicity (f)

   

X

  

 QLQ-C30 et QLQ-PR25

X

 

X

X

  

 PSA

X

 

X (f)

X (f)

X (f)

 

 Testosterone

X (g)

 

X

X

X

 

ADT (c) + RT

 

X

    
  1. (a) maximum 3 months prior to initiation of ADT
  2. (b) at progression
  3. (c) 6 months treatment staring on RT day 1 or maximum 3 months prior to RT
  4. (d) once per week during RT
  5. (e) biochemical progression = PSA higher than inclusion PSA with 2 successive rises in the same laboratory
  6. (f) NCI-CTCAE v4.0
  7. (g) 28 days prior to ADT