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Table 1 Table 1 Schedule of study parameters and collection: months 0–24 and beyond 24 months

From: Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan

 

Pre-randomisation

Baseline

Months 0–24

Follow-up visit every 2 months (± 2 weeks);

MRI every 3 months (± 4 weeks)

Intracranial failure

 

2

3

4

6

8

9

10

12

14

15

16

18

20

21

22

24

Initial local treatment and confirmation of melanoma

X

                  

Urine pregnancy test

 

X

                 

eGFR

X

                  

MRI of brain

X

X

 

X

 

X

 

X

 

X

 

X

 

X

 

X

 

X

X

Disease statusa

X

Any imaging after randomisation will be as clinically indicated by local protocol or for suspicion of systemic progression..

ECOG Performance Status

X

 

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

AE/SAE reporting

 

X

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

Medical history

 

X

                 

Physical examination

 

X

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

Systemic therapies

 

X

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

Steroid use

 

X

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

Participation in other clinical trials

 

X

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

QoL questionnaires

 

X

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

Health economic resource use questionnaires

 

X

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

NCF assessments

 

X

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

WBRT

For patients randomised to the WBRT treatment arm:

WBRT is to commence < 4 weeks from randomisation and no more than 8 weeks from completion of local brain metastases treatment

For patients who receive salvage WBRT during follow-up:

Patients may undergo salvage WBRT at any time during the observation period, at the local investigator’s discretion

 

Beyond 24 monthsb

 
 

Patients who have experienced intracranial failure by 24 months

Follow-up visit every 2 months (± 2 weeks);

MRI every 3 months (± 4 weeks)

Patients who have NOT had an intracranial failure by 24 months

Follow-up visit every 3 months (± 2 weeks);

MRI every 6 months (± 4 weeks)

Intracranial failure

 

26

27

28

30

32

33

34

36

38

39

40

42

44

45

46

48

27

30

33

36

39

42

45

48

MRI of brain

 

X

 

X

 

X

 

X

 

X

 

X

 

X

 

X

 

X

 

X

 

X

 

X

X

Disease statusa

Any imaging after randomisation will be as clinically indicated by local protocol or for suspicion of systemic progression

ECOG Performance Status

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

X

X

X

X

X

X

X

X

AE/SAE reporting

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

X

X

X

X

X

X

X

X

Physical examination

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

X

X

X

X

X

X

X

X

Systemic therapies

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

X

X

X

X

X

X

X

X

Steroid use

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

X

X

X

X

X

X

X

X

Participation in other clinical trials

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

X

X

X

X

X

X

X

X

QoL questionnaires

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

X

X

X

X

X

X

X

X

Health economic resource use questionnaires

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

X

X

X

X

X

X

X

X

NCF assessments

X

 

X

X

X

 

X

X

X

 

X

X

X

 

X

X

X

X

X

X

X

X

X

X

X

WBRT

For patients randomised to the WBRT treatment arm:

WBRT is to commence < 4 weeks from randomisation and no more than 8 weeks from completion of local brain metastases treatment

For patients who receive salvage WBRT during follow-up:

Patients may undergo salvage WBRT at any time during the observation period, at the local investigator’s discretion

  1. a Disease status assessed by staging CT or PET scans
  2. b Follow-up visits will continue beyond month 48 and until death
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Trials

ISSN: 1745-6215