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Table 3 SIRFLOX study assessment schedule

From: Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study

  Screening During chemotherapy Post-progression follow-up
Evaluation/examination (≤28 d before randomisation) Day 1 Day 3 or 4 of cycle 1 Every 2 weeks ±1 weeka (every 12 weeks)
Informed consent X     
Demographics X     
Medical history X     
Concomitant illnesses X     
Concurrent medications X X X X  
Clinical assessment and physical examination X X   X  
Performance status X X   X  
Haematologyb X X   X  
Biochemistryc X X   X  
Pregnancy test X     
Serum CEA X    Xd  
CT of chest/abdomen/pelvis X    Xe X
Assessment for resection X    Xe  
Hepatic angiogramf   Xg    
99mTc-MAA lung shunt studyf   Xg    
Adverse events From consent until 28 days after the last dose of protocol chemotherapy
EQ-5D HRQoL X    Xh  
Ongoing review of treatment and survival      X
  1. aBefore each cycle of chemotherapy unless otherwise stated.
  2. bMeasurement of haemoglobin, platelets, white blood cells, absolute neutrophils and absolute lymphocytes.
  3. cUrea, creatinine, liver enzymes, alkaline phosphatase, bilirubin and albumin.
  4. dEvery 4 weeks.
  5. eEvery 8 weeks.
  6. fIntervention arm only.
  7. g7 days ±4 days before SIRT.
  8. hEQ-5D questionnaire completed at 3, 6, 12, 24, 36 months, and annually thereafter.
  9. i4 weeks and 12 months after starting treatment.
  10. CEA = Carcinoembryonic antigen; CT = Computed tomography.