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Table 2 Detailed overview of the treatment protocol

From: A prospective, non-randomized phase II trial of Trastuzumab and Capecitabine in patients with HER2 expressing metastasized pancreatic cancer

Cycle 0 1 2 3 4 5 6 7
day   1 8 15 22 29 36 43 50 57 64 71 78 85 92 99 106 113 120 127 134 141
history X                      
eligibility criteria X                      
informed consent X                      
Trastuzumab i.v.   X1 X X X X X X X X X X X X X X X X X X X X
Capecitabine p.o.   1–14   22–35   43–58   64–77   85–98   106–119   127–140  
vital signs, physical exam2 X X X X X X X X X X X X X X X X X X X X X X
analgesic consumption3 X X X X X X X X X X X X X X X X X X X X X X
pain assessment3 X X X X X X X X X X X X X X X X X X X X X X
quality of life4 X        X       X       X   
diagnostic/remission5 X        X       X       X   
CA 19-9 level6 X X*    X    X    X    X    X    X   
hematology7 X X# X X X X X X
blood chemistry8 X X    X    X    X    X    X    X   
toxicity (NCI CTC 3.0)9 X     X    X    X    X    X    X   
ECG X              X         
TEE X              X         
  1. 1. Trastuzumab: initial dose 4 mg/kg body weight, subsequent cycles 2 mg/kg body weight
  2. 2. vitals signs and physical exam: height, weight, Karnofsky performance status, pulse rate, blood pressure, temperature
  3. 3. analgesic consumption and pain symptoms (visual analogue scale)
  4. 4. EORTC QLQ-C30 (v3.0) questionnaire
  5. 5. tumor diagnostic: imaging study, HER2/neu analysis; status of remission for at least 12 weeks: CT- or MRI Abdomen, CXR (CT-chest)
  6. 6. CA19-9: serum level (ELSIA), * no measurement if between time point 0 and 1st day of cycle 1 < 4 weeks
  7. 7. Hematology: complete blood count (CBC), differential blood count; # no measurement if between time point 0 and 1st day of cycle 1 < 1 weeks; §only CBC
  8. 8. Blood chemistry: total bilirubin, ALT, AST, alk. Phos., γ-GT, total protein, albumin, creatinine, uric acid, sodium, potassium, calcium
  9. 9. NCI: CTC vers. 3.0. If toxicity > 2 reevaluation by study physical