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Table 1 Flow chart for the experimental study arm

From: TRIM study protocol - a prospective randomized multicenter Trial to assess the Role of Imaging during follow-up after radical surgery of stage IIB-C and III cutaneous malignant Melanoma

Assessments:

Baseline

6 months +/− 28 days

12 months +/− 28 days

18 months +/− 28 days

21 months +/− 28 days

24 months +/− 28 days

30 months +/− 28 days

36 months +/− 28 days

Year 4 (OS only)

Year 5 (OS only)

 

1–8 weeks after final surgery(a)

  

Visit applicable for stage III patients only

Letter contact

 

Visit applicable for stage III patients only

   

Informed consent (within 8 weeks prior to randomization) (b)

X

         

Inclusion/exclusion criteria

X

         

Demographics

X

         

Cancer/treatment history (c)

X

         

Physical examination (d)

X

X

X

X (d)

 

X

X (d)

X

  

Biochemistry (e)

X 

X

X

  

X

 

X

  

CT scan thorax/abdomen/brain or iv contrast enhanced whole-body FDG-PET/CT including brain (f)

X (i)

X

X

  

X

 

X

  

Ultrasound of affected lymph node location (g)

   

X (g)

  

X (g)

   

HRQoL (h)

X

 

X

 

X

X

 

X

  
  1. aAn imaging examination carried out before but within two months of randomization is adequate as baseline assessment for both groups under the prerequisite that the same method is used for future examinations. Final surgery is defined as wide excision and/or sentinel node biopsy or lymph-node dissection.
  2. bWritten informed consent must be obtained before any study-specific screening procedures are performed.
  3. cIncludes thickness of primary tumour, number of examined nodes/nodes with metastases, TNM staging, postoperative treatment (i.e. adjuvant radiotherapy, adjuvant systemic treatment).
  4. dTo be performed according to clinical routines. Months 18 and 30: Visit applicable for stage III patients only. FU year 4 and 5 is for overall survival only. If visit at the clinic is not planned, a review of medical records is sufficient.
  5. eBiochemistry: s-creatinine, S-S100B, ALP, LDH, AST and/or ALT.
  6. fThe mode of imaging (CT scan of the lungs, abdomen and brain or i.v. contrast enhanced whole body FDG-PET-CT including brain) is chosen by the investigator at baseline and the same mode is used for the subsequent examinations.
  7. gTo be done shortly before the scheduled visits, that are not preceded with whole body imaging examination, for stage III patients who have not had lymph node dissection.
  8. hHRQoL (EORTC QLQ-C30 and HAD) will be carried out at sites with an oncologist as PI. The assessments will be performed at the study center, just before the study visits, preferably on a web-based device (if not available, paper formula is accepted). At 21 months the HRQoL will be completed remotely between on-site visits.
  9. iIf not performed within 8 weeks before randomization, it should be done within 28 days post-randomization at the latest.
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BMC Cancer

ISSN: 1471-2407

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