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Table 2 Flow chart study procedures

From: Trial on Refinement of Early stage non-small cell lung cancer. Adjuvant chemotherapy with pemetrexed and cisplatin versus vinorelbine and cisplatin: The TREAT protocol

    Adjuvant Chemotherapy Phase    
  Pre-study Phase Pre-study Phase Cycle 1 Cycle 2 Cycle 3 Cycle 4 1st follow up (30 days after end of chemo-therapy) Further Follow-Up
Treatment Arm    A B A B A B A B A B A &B
Timeframe (days) -28 prior to Surgery -14 prior to Chemotherapy start 1–21 1–28 22–42 29–56 43–63 57–84 64–84 85–112 114 142 until 3 years after CTX
day of visit -28 prior to Surgery -14 prior to Chemotherapy start 1 1, 8, 15, 22 22 29, 36, 43, 50 43 57, 64, 71, 78 64 85, 92, 99, 106 114 142 starting 3 month after 1st follow up in Years 1 & 2: 3-monthly, then 6-monthly
Informed Consent   X            
Demography   X            
Pregnancy test   X1            
Medical history, Signs and symptoms   X            
Neurological Status   X X X X X    
Clinical Examination2   X2 X2 X2 X2 X2 X2 X2
Concomitant medication   X X X X X X X
Laboratory hematology   X X3,4 X3,4 X3,4 X3,4 X X
Laboratory hepatic   X X4 X4 X4 X4 X X
Laboratory renal   X X4 X4 X4 X4    
Laboratory electrolytes   X X4 X4 X4 X4    
Laboratory coagulation   X            
12-lead ECG   X            
Assessment of LVEF9   X            
Chest-X-ray   X          X5 X5
Abdomen ultrasound X6           X10 X10
MRT or CT skull X             
CT6 lower liver marginliver X             
Assessment of vital/total capacity   X          X  
Assessment of FEV1   X          X  
Assessment of absolute DLCO or BGA under resting conditions   X          X  
Bone Scintigraphy7 X             
Audiometry8   X            
Compliance   X X X X X    
Adverse events   X X X X X X  
Follow-Up tumor assessment5            X X
  1. 1 in women with child-bearing potential
  2. 2 Clinical examination including physical examination, neurologic assessment, height (height only to be assessed at baseline), weight, vital signs, Karnofsky or ECOG Performance Status at the beginning of each chemotherapy cycle.
  3. 3 hematology parameters, including Hb, platelets, WBC, ANC at least once weekly during chemotherapy phase
  4. 4 Three days prior to or at least at day 1 of each chemotherapy-cycle
  5. 5 Relapse of disease should be confirmed by imaging techniques
  6. 6 CT scan of the thorax and abdomen including adrenal glands and the right lower liver margin (in case adrenal glands are not available further CT scan of the abdomen is mandatory; if only right lower liver margin is not available assessment by either CT scan of abdomen or abdominal ultrasound should be performed)
  7. 7 If a FDG-PET scan has been performed, bone scintigraphy can be omitted
  8. 8 Optional; patients with clinical suspicion of altered hearing capability or symptoms should undergo further evaluation by audiometry
  9. 9 Echocardiography optional, mandatory only in case of doubt whether cardiac function allows Cisplatin chemotherapy
  10. 10 optional, left to the discretion of the center prior to study initiation of the center