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Table 2 Schedule of activites

From: MR-guided adaptive stereotactic body radiotherapy (SBRT) of primary tumor for pain control in metastatic pancreatic ductal adenocarcinoma (mPDAC): an open randomized, multicentric, parallel group clinical trial (MASPAC)

Procedures Screening and inclusion Baseline6 MR-guided adaptive SBRT (Arm A only) Week 4 post randomization Every 4 weeks post randomization1 Every 3 months post randomization Study termination (18 months post randomization)
Informed consent, demographic data, in-/exclusion criteria, medical history       
Physical examination9  2  
Laboratory assessment8    
Study specific blood and urine collection7    3  
Pain assessment10   4 5  
Assessment of biliary complications11    
Assessment of nutritional status12    
Assessment of quality of life13    
Randomization     
Review of imaging     
MR-guided adaptive SBRT       
Concomitant disease    
Concomitant medication  
Adverse events and toxicity    
  1. 1Either during clinical visit or phone call
  2. 2Vital signs only
  3. 3Only week 24
  4. 4NRS
  5. 5NRS and Brief Pain Inventory
  6. 6Study specific examinations and blood withdrawal should only be performed after having obtained written informed consent from the patient and before randomization of the patient
  7. 7Study specific blood withdrawal for exploratory objectives will be conducted in conjunction with clinically indicated routine blood draws
  8. 8Routine laboratory: full blood count, differential blood count, aPTT, INR, Sodium, Potassium, Creatinine, serum urea, Bilirubin (total and conjugated), ASAT, ALAT, gGT, AP, Lipase, CRP, LDH, CA19.9, Albumin, Phosphate, Magnesium, Calcium, 25-OH-Vitamin D, HbA1c. The pregnancy test: bHCG urine dip stick (only in women of child bearing age at baseline) should be performed at baseline and the result should be known before randomization
  9. 9Physical examination includes: clinical investigation of skin, chest and abdomen; vital signs: blood pressure, pulse, temperature, breath rate, oxygen saturation; ECOG by physician or trained specialized nurse
  10. 10Pain assessment: Brief pain Inventory questionnaire, intensity assessed by NRS
  11. 11Biliary complications: cholangitis, post-hepatic cholestasis requiring biliary stenting or PTCD
  12. 12Nutritional status: BMI, BIA
  13. 13Quality of life: EQ-5D-5L and Fact Hepatobiliary Symptom Index FHSI-8