INITIAL ACTION IN INTRACRANIAL TUMORS · for teratoma modified according to treatment) Dr....

APPENDIX C

flow charts

1. Initial action 32. Grouping for diagnosis 53. Grouping for dissemination 74. Investigation flow chart Germinoma (and

teratoma) 9

5. Investigation flow chart Non-Germinoma 116. Summary of Recommended Follow-up

Investigations in Malignant GCT 13

7. Time frame for return of documentation 15

INIT

IAL

AC

TIO

N IN

INTR

AC

RA

NIA

L TU

MO

UR

S - G

ERM

CEL

L TU

MO

UR

SU

SPEC

TED

(e.g

. PIN

EAL

OR

SU

PRA

SELL

AR

TU

MO

UR

) -

D

I

A

G

G

N

O

R

S

I O

S

U

D

I P

S

S

I

E

seve

rely

rais

ed

intra

cran

ial

pres

sure

or

com

atos

e ra

ised

intra

cran

ial

pres

sure

bu

t sta

ble

norm

al in

tracr

ania

l pr

essu

re a

nd n

o ac

ute

neur

olog

ical

sy

mpt

oms

PLE

AS

E N

OTE

in a

ny c

ases

rece

ivin

g ne

uros

urgi

cal i

nter

vent

ion,

CS

F sh

ould

be

sam

pled

for m

arke

rs a

nd c

ytol

ogy

befo

re v

entri

culo

stom

y or

bio

psy

is u

nder

take

n

* bi

opsy

is n

ot re

quire

d w

hen

mar

kers

are

pos

itive

Rei

mag

ing

(inc.

spi

ne if

not

alre

ady

done

) sh

ould

be

carr

ied

out w

ithin

48

h of

sur

gica

l res

ectio

n

M

N

I

N

G

A

T

I

O

N

emer

genc

y im

agin

g C

T/M

RI b

rai n

Ser

um

mar

kers

M

RI

cran

ial

+ sp

inal

C

SF

cyto

logy

C

SF

mar

k ers

(te

mpo

rary

) shu

nt/

vent

ricul

osto

my

bi

opsy

neur

osur

gica

l int

erve

ntio

n

MR

I cr

ania

l +

spin

al

Ser

um

mar

k ers

CS

F cy

tolo

gy

shun

t /

vent

ricul

ost o

my

bi

opsy

*

CS

F

neur

osur

gica

l int

erve

ntio

n

mar

kers

MR

I cr

ania

l +

spin

al

Ser

um

mar

kers

CS

F cy

tolo

gy

C

SF

mar

k ers

lum

bar p

unct

ure

bi

opsy

*

neur

osur

g.

SIO

P C

NS

GC

T II,

Fin

ale

Ver

sion

2, 1

5.06

.201

1, A

ppen

dix

C.1

S

eite

1 v

on 1

Appendix C page 3/16

GROUPING FOR DIAGNOSIS

SIOP CNS GCT II, Finale Version 2, 15.06.2011, Appendix C.2 Seite 1 von 1

no

Serum AFP > 25 ng/ml or

Serum total HCG > 50 IU/l or

CSF AFP > 25 ng/ml or

CSF total HCG > 50 IU/l

* only in case of bifocal disease (only pineal+suprasellar)

diagnosis of germinoma is accepted without biopsy

histological verification*

only Teratoma

CHC, YST or EC (part) found

mal. Non-Germinoma (NGGCT)

mal. Non-Germinoma (NGGCT)

Germinoma (GER)

Teratoma (TER)

no

no

no

yes

yes

yes

yes

no GCT

Germinoma found

Abbreviations: CHC = Chorio-Carcinoma YST = Yolk Sac Tumour EC = Embryonal


GROUPING FOR DISSEMINATION

no

CSF cytology

MRI spinal

yes* metastatic* disease

cranial MRI: two or more foci?

CSF cytology

yes metastatic disease

spinal MRI: positive?

no

no

metastatic disease

CSF-cytology: positive?

yes non-metastatic

disease * In case of bifocal tumor (only pineal+suprasellar) and negative spinal MRI and negative CSF-cytology, disease is classified as non-metastatic.

SIOP CNS GCT II, Finale Version 2, 15.06.2011, Appendix C.3 Seite 1 von 1


SIO

P C

NS

GC

T II

– In

trac

rani

al G

CTs

Sum

mar

y of

Inve

stig

atio

ns

Req

uire

d B

efor

e, D

urin

g an

d A

fter

Trea

tmen

t: G

erm

inom

a (a

sses

smen

t can

be

also

use

d fo

r ter

atom

a m

odifi

ed a

ccor

ding

to tr

eatm

ent)

Dr.

Cal

amin

us, C

linic

for P

edia

tric

Hem

atol

ogy

and

Onc

olog

y, U

nive

rsity

Chi

ldre

n's

Hos

pita

l, D

– 4

8129

Mün

ster

X

= R

equi

red

(X) =

If in

dica

ted

GER

MIN

OM

A A

ND

N

GG

CT

All

Ger

min

omas

N

on-M

etas

tatic

Ger

min

oma

ON

LY

All

Ger

min

omas

Non

-M

etas

tatic

G

erm

inom

a

Met

asta

tic/

Inco

mpl

etel

y S

tage

d G

erm

inom

a

All

Ger

min

omas

Al

l G

erm

inom

as

D

iagn

osis

Pr

e-tre

atm

ent

Bef

ore

each

cou

rse

of

Che

mot

hera

py

Afte

r 4 c

ours

es

of c

hem

othe

rapy

R

adio

ther

apy

(T)

End

of

treat

men

t E

nd o

f Tre

atm

ent

2 yr

s la

ter

5 yr

s la

ter

Cou

rse

1 2

3 4

D

ay

1 22

43

64

Car

bopl

atin

+ E

topo

side

(A)

Ifo

sfam

ide

+ E

topo

side

(B)

MR

I cra

nial

X

(C)

X

(D)

X

X

M

RI s

pina

l X

(C)

X

X

Tu

mou

r mar

ker i

n se

rum

+ C

SF

(AFP

+ to

tal H

CG

) X

(E)

X

(F)

X

(G)

X

CS

F C

ytol

ogy

(H)

X (E

)

X

Biop

sy (I

) (X

)

Fina

l sta

ge +

risk

stra

tific

atio

n X

In

clus

ion/

excl

usio

n cr

iteria

X

In

form

ed c

onse

nt

X

Full

bloo

d co

unt +

Diff

X

X X

X

X

C

hem

istry

(J)

X

(K)

X

X

X

X

GFR

or c

reat

inin

e cl

eara

nce

(L)

X

X

X

Vira

l ser

olog

y (M

)

X

En

docr

ine

eval

uatio

n (N

)

X

X

X

H

earin

g as

sess

men

t (O

)

X

(X)

(X)

(X)

X X

Oph

thal

mol

ogic

al a

sses

smen

t

X

Q

ualit

y of

Life

ass

essm

ent

X(P*

)

X X

X X(

P*)

Neu

roco

gniti

ve a

sses

smen

t (X

)

X X

Pre

serv

atio

n of

ferti

lity

(Q)

(X

)

Pr

egna

ncy

test

(X)

Clin

ical

exa

min

atio

n

X

X X

X X

(R)

W

eigh

t

X

X X

X

R

esec

tion

(X)

U

rine

chem

istry

(S)

X

X

SA

Es

Mus

t be

repo

rted

to th

e SA

E M

anag

emen

t Mün

ster

by

the

end

of th

e ne

xt b

usin

ess

day

inte

rnat

. tria

l no.

: └┴┴┴┘

cent

re n

o.:

└┴┴┘

trial

no.

: └┴┴┴┴┴┴┴┘

se

x:└┘

MM

DD

Y Y

Y Y

da

te o

f birt

h

SIO

P C

NS

GC

T II,

Fin

ale

Ver

sion

2, 1

5.06

.201

1, A

ppen

dix

C.4

S

eite

1 v

on 2


SIO

P C

NS

GC

T II,

Fin

ale

Ver

sion

2, 1

5.06

.201

1, A

ppen

dix

C.4

S

eite

2 v

on 2

A.

Car

bopl

atin

on

Day

1; E

topo

side

on

Day

s 1,

2 a

nd 3

. B

. Ifo

sfam

ide

on D

ays

1, 2

, 3, 4

and

5; E

topo

side

on

Day

s 1,

2 a

nd 3

. C

. M

RI s

houl

d be

per

form

ed b

efor

e bi

opsy

and

with

in 4

8 ho

urs

of s

urge

ry, i

f res

ectio

n is

per

form

ed (n

ot re

quire

d af

ter b

iops

y on

ly).

Spi

nal M

RI s

houl

d id

eally

be

perfo

rmed

be

fore

lum

bar p

unct

ure

and

surg

ery.

Cas

es o

f bifo

cal d

isea

se a

nd n

egat

ive

tum

our m

arke

rs in

ser

um a

nd C

SF

mus

t be

conf

irmed

by

cent

ral r

evie

w o

f the

MR

I (he

ad a

nd

spin

e).

D.

Sca

ns o

f pat

ient

s w

ith c

ompl

ete

resp

onse

(CR

) mus

t be

revi

ewed

by

the

natio

nal r

efer

ence

neu

rora

diol

ogis

t prio

r to

deliv

ery

of v

entri

cula

r rad

ioth

erap

y.

E.

CS

F sa

mpl

ing

with

in a

sur

gica

l int

erve

ntio

n sh

ould

be

perfo

rmed

prio

r to

biop

sy o

r ven

tricu

lost

omy.

F.

S

erum

mar

kers

in a

ll ca

ses;

CS

F m

arke

rs in

all

case

s of

dou

bt

G.

Ser

um m

arke

rs o

nly

H.

Obt

aine

d by

lum

bar p

unct

ure

or b

y ve

ntric

ular

tap

at d

iagn

osis

. If n

o cy

tolo

gy h

as b

een

colle

cted

bef

ore

oper

atio

n, a

lum

bar p

unct

ure

shou

ld b

e do

ne o

n da

y 10

(or l

ater

) af

ter s

urge

ry.

I. If

mar

ker l

evel

s ar

e no

rmal

or b

elow

or e

qual

25

ng/m

l (A

FP) a

nd b

elow

or e

qual

50

IU/l

(tota

l HC

G) a

bio

psy

shou

ld b

e pe

rform

ed u

nles

s bi

foca

l.

J.

Sod

ium

, Pot

assi

um, U

rea ,C

reat

inin

e, A

LT/A

ST,

Alk

alin

e P

hosp

hata

se, B

ilirub

in, A

lbum

in, M

agne

sium

, Cal

cium

, Pho

spha

te

K.

As

per J

plu

s LD

H

L.

In p

atie

nts

due

to re

ceiv

e ch

emot

hera

py: G

FR e

stim

ated

by

radi

oiso

tope

cle

aran

ce, o

r dire

ct m

easu

rem

ent o

f urin

ary

crea

tinin

e cl

eara

nce

M

. A

ccor

ding

to n

atio

nal p

ract

ice

N.

Incl

udin

g he

ight

, sitt

ing

heig

ht, w

eigh

t, pu

berta

l sta

tus,

ser

um c

once

ntra

tions

of T

hyro

tropi

n (T

SH

), G

onad

otro

pins

and

sex

ste

roid

s, a

ge a

t ons

et o

f pub

erty

, men

arch

e an

d su

pple

men

tal u

se o

f hor

mon

e th

erap

y.

O.

Pur

e To

ne A

udio

met

ry

P.

Qua

lity

of li

fe s

houl

d be

car

ried

out a

s so

on a

s po

ssib

le a

t dia

gnos

is (p

refe

rabl

y w

ithin

2 w

eeks

and

def

inite

ly b

efor

e th

e st

art o

f rad

ioth

erap

y (fo

r rad

ioth

erap

y on

ly p

atie

nts)

or

the

2nd c

ours

e of

che

mot

hera

py (c

ombi

ned

treat

men

t) an

d at

the

end

of tr

eatm

ent.

*Soc

ial a

nd li

ving

env

ironm

ent e

stim

ated

toge

ther

with

Qua

lity

of li

fe a

t dia

gnos

is a

nd

five

year

s la

ter.

Q.

For a

dole

scen

t mal

es th

e po

ssib

ility

of s

perm

cry

opre

serv

atio

n sh

ould

be

disc

usse

d. In

pos

tpub

erta

l girl

s or

you

ng w

omen

, gon

adal

pro

tect

ion

may

be

cons

ider

ed, a

nd

shou

ld b

e ba

sed

on lo

cal o

r nat

iona

l rec

omm

ende

d pr

actic

e. S

ee a

lso

5.8

R.

Incl

udin

g ne

urol

ogic

al e

xam

inat

ion

S.

Urin

e os

mol

ality

(ear

ly m

orni

ng) a

nd p

hosp

hate

, cre

atin

ine

for c

alcu

latio

n of

tubu

lar r

eabs

orpt

ion

of p

hosp

hate

. T.

Fo

llow

ing

4 co

urse

s of

che

mot

hera

py fo

r Non

-Met

asta

tic G

erm

inom

a. P

atie

nts

with

Met

asta

tic/In

com

plet

ely

Sta

ged

Ger

min

oma

do n

ot re

ceiv

e ch

emot

hera

py.


SIO

P C

NS

GC

T II

– In

trac

rani

al G

CTs

Sum

mar

y of

Inve

stig

atio

ns

Req

uire

d B

efor

e, D

urin

g an

d A

fter T

reat

men

t: M

alig

nant

Non

-Ger

min

omat

ous

GC

T D

r. C

alam

inus

, Clin

ic fo

r Ped

iatri

c H

emat

olog

y an

d O

ncol

ogy,

U

nive

rsity

Chi

ldre

n's

Hos

pita

l, D

– 4

8129

Mün

ster

X

= R

equi

red

(X) =

If in

dica

ted

D

iagn

osis

P

re-tr

eatm

ent

Bef

ore

each

cou

rse

of

chem

othe

rapy

B

efor

e 4t

h co

urse

of

chem

othe

rapy

Afte

r 4

cour

ses

of

chem

othe

rapy

Rad

ioth

erap

yE

nd o

f Tr

eatm

ent

2 yr

s la

ter

5 yr

s la

ter

Cou

rse

1 2

3 4

Day

1

22

43

SR

: C

ispl

atin

, Ifo

sfam

ide

+ E

topo

side

(A)

HR

:C

ispl

atin

, Ifo

sfam

ide

+ E

topo

side

(A)

○H

igh

Dos

e P

EI +

PB

SC

T (B

)

○ ○

MR

I cra

nial

X

(C)

X (C

) X

X

MR

I spi

nal

X (C

)

X

(D)

X (D

)

X

Tu

mou

r mar

ker i

n se

rum

+ C

SF

(AFP

+ to

tal

HC

G)

X (E

) X

(F)

X (G

) X

(G)

X (G

) X

(H)

X (H

)

X (I)

CS

F C

ytol

ogy

(J)

X (E

)

X

(K)

X (K

)

X (L

)

Bi

opsy

/Res

ectio

n (M

) (X

)

(X

)

Fina

l sta

ge +

risk

stra

tific

atio

n X

Incl

usio

n/ex

clus

ion

crite

ria

X

In

form

ed c

onse

nt

X

Fu

ll bl

ood

coun

t + D

iff

X

X

X X

C

hem

istry

(N)

X

(O)

X

X X

X

G

FR o

r cre

atin

ine

clea

ranc

e (P

)

X

X

(X)

X

V

iral s

erol

ogy

(Q)

X

En

docr

ine

eval

uatio

n (R

)

X

X

Hea

ring

asse

ssm

ent (

S)

X

(X

) X

(X)

X

O

phth

alm

olog

ical

ass

essm

ent

X

Q

ualit

y of

Life

X(

T*)

X

X X(

T*)

Neu

roco

gniti

ve a

sses

smen

t (X

)

X

X P

rese

rvat

ion

of fe

rtilit

y (U

)

(X)

Pr

egna

ncy

test

(X)

C

linic

al e

xam

inat

ion

(V)

X X

X X

(W)

X (W

)

W

eigh

t

X

X X

X

Urin

e C

hem

istry

(X)

X

X

S

AE

s

Mus

t be

repo

rted

to th

e SA

E M

anag

emen

t Mün

ster

by

the

end

of th

e ne

xt b

usin

ess

day

inte

rnat

. tria

l no.

: └┴┴┴┘

cent

re n

o.:

└┴┴┘

trial

no.

: └┴┴┴┴┴┴┴┘

se

x:└┘

MM

DD

Y Y

Y Y

da

te o

f birt

h

SIO

P C

NS

GC

T II,

Fin

ale

Ver

sion

2, 1

5.06

.201

1, A

ppen

dix

C.5

S

eite

1 v

on 2


SIO

P C

NS

GC

T II,

Fin

ale

Ver

sion

2, 1

5.06

.201

1, A

ppen

dix

C.5

S

eite

2 v

on 2

A.

Com

men

ce a

s so

on a

s po

ssib

le a

fter d

iagn

osis

. Cis

plat

in o

n D

ay 1

, 2, 3

, 4 a

nd 5

; Eto

posi

de o

n D

ays

1, 2

and

3; I

fosf

amid

e on

Day

s 1,

2 ,3

, 4 a

nd 5

B

. H

igh

dose

PE

I = C

ispl

atin

on

Day

1, 2

, 3, 4

and

5; E

topo

side

on

Day

s 1,

2, 3

, 4 a

nd 5

; Ifo

sfam

ide

on D

ays

1, 2

,3, 4

and

5. P

erip

hera

l blo

od s

tem

cel

l tra

nspl

ant =

har

vest

st

em c

ells

follo

win

g 2nd

cou

rse

of P

EI;

rein

fuse

on

day

7 of

hig

h do

se P

EI.

C.

MR

I sho

uld

be p

erfo

rmed

bef

ore

biop

sy (i

f per

form

ed) a

nd w

ithin

48

hour

s of

sur

gery

, if r

esec

tion

is p

erfo

rmed

(not

requ

ired

afte

r bio

psy

only

). S

pina

l MR

I sho

uld

idea

lly

be p

erfo

rmed

bef

ore

lum

bar p

unct

ure

and

surg

ery.

It is

stro

ngly

reco

mm

ende

d th

at s

cans

of p

atie

nts

with

resi

dual

tum

our a

t thi

s st

age

are

revi

ewed

by

the

natio

nal

refe

renc

e ne

uror

adio

logi

st.

D.

If in

volv

ed a

t dia

gnos

is. I

t is

stro

ngly

reco

mm

ende

d th

at s

cans

of p

atie

nts

with

resi

dual

tum

our a

t thi

s st

age

are

revi

ewed

by

the

natio

nal r

efer

ence

neu

rora

diol

ogis

t. E

. C

SF

sam

plin

g w

ithin

a s

urgi

cal i

nter

vent

ion

shou

ld b

e pe

rform

ed p

rior t

o bi

opsy

or v

entri

culo

stom

y.

F.

If >

2 w

eeks

bet

wee

n di

agno

sis

and

star

t of t

reat

men

t if r

aise

d at

dia

gnos

is.

G.

Ser

um m

arke

rs o

nly.

H

. S

erum

mar

kers

in a

ll ca

ses.

CS

F is

man

dato

ry if

rais

ed a

t dia

gnos

is.

I. S

erum

mar

kers

in a

ll ca

ses.

SR

pat

ient

s re

quire

CS

F on

ly if

not

neg

ativ

e at

last

eva

luat

ion.

J.

O

btai

ned

by lu

mba

r pun

ctur

e or

by

vent

ricul

ar ta

p at

dia

gnos

is. I

f no

cyto

logy

has

bee

n co

llect

ed b

efor

e op

erat

ion,

a lu

mba

r pun

ctur

e sh

ould

be

done

on

day

10 (o

r lat

er)

afte

r sur

gery

. K

. M

anda

tory

if p

ositi

ve a

t dia

gnos

is.

L.

All

HR

pat

ient

s. O

nly

requ

ired

in S

R p

atie

nts

if po

sitiv

e at

dia

gnos

is.

M.

If m

arke

r lev

els

are

norm

al o

r bel

ow o

r equ

al 2

5 ng

/ml (

AFP

) and

bel

ow o

r equ

al 5

0 IU

/l (to

tal H

CG

) a b

iops

y sh

ould

be

perfo

rmed

. R

esec

tion

is n

ot in

dica

ted

at th

e tim

e of

dia

gnos

is b

ut re

sect

ion

of re

sidu

al s

houl

d be

con

side

red

at th

e tim

e of

reas

sess

men

t bef

ore

(sta

ndar

d ris

k) o

r afte

r (hi

gh ri

sk) 4

th c

ours

e of

che

mot

hera

py

N.

Sod

ium

, Pot

assi

um, U

rea,

Cre

atin

ine,

ALT

/AS

T, A

lkal

ine

Pho

spha

tase

, Bilir

ubin

, Alb

umin

, Mag

nesi

um, C

alci

um, P

hosp

hate

O

. A

s pe

r N p

lus

LDH

. P

. G

FR e

stim

ated

by

radi

oiso

tope

cle

aran

ce, o

r dire

ct m

easu

rem

ent o

f urin

ary

crea

tinin

e cl

eara

nce.

Onl

y H

R p

atie

nts

requ

ire G

FR b

efor

e th

e 4th

cou

rse

of c

hem

othe

rapy

. Q

. A

ccor

ding

to n

atio

nal p

ract

ice

R.

Incl

udin

g he

ight

, wei

ght,

pube

rtal s

tatu

s, s

erum

con

cent

ratio

ns o

f Thy

rotro

pin

(TS

H),

Gon

adot

ropi

ns a

nd s

ex s

tero

ids,

age

at o

nset

of p

uber

ty, m

enar

che

and

supp

lem

enta

l use

of h

orm

one

ther

apy.

S

. P

ure

Tone

Aud

iom

etry

T.

Q

ualit

y of

life

sho

uld

be c

arrie

d ou

t as

soon

as

poss

ible

at d

iagn

osis

(pre

fera

bly

with

in 2

wee

ks a

nd d

efin

itely

bef

ore

the

star

t of r

adio

ther

apy

(for r

adio

ther

apy

only

pa

tient

s) o

r the

2nd

cou

rse

of c

hem

othe

rapy

(com

bine

d tre

atm

ent)

and

at th

e en

d of

radi

othe

rapy

. *S

ocia

l and

livi

ng e

nviro

nmen

t est

imat

ed to

geth

er w

ith Q

ualit

y of

life

at

diag

nosi

s an

d fiv

e ye

ars

late

r.

U.

For a

dole

scen

t mal

es th

e po

ssib

ility

of s

perm

cry

opre

serv

atio

n sh

ould

be

disc

usse

d. In

pos

tpub

erta

l girl

s or

you

ng w

omen

, gon

adal

pro

tect

ion

may

be

cons

ider

ed, a

nd

shou

ld b

e ba

sed

on lo

cal o

r nat

iona

l rec

omm

ende

d pr

actic

e.

V.

Incl

udin

g ne

urol

ogic

al e

xam

inat

ion

W.

Urin

e os

mol

ality

(ear

ly m

orni

ng) a

nd p

hosp

hate

, cre

atin

ine

for c

alcu

latio

n of

tubu

lar r

eabs

orpt

ion

of p

hosp

hate

. X

. Fo

r all

NG

GC

Ts (H

R a

nd S

R) i

n pa

tient

s ol

der t

han

or e

qual

to 6

yea

rs o

f age

.


SIO

P C

NS

GC

T II

– In

trac

rani

al G

CTs

Sum

mar

y of

Inve

stig

atio

ns

Sum

mar

y of

Rec

omm

ende

d Fo

llow

-up

Inve

stig

atio

ns in

Mal

igna

nt G

CTs

(G

erm

inom

a an

d N

GG

CT)

D

r. C

alam

inus

, Clin

ic fo

r Ped

iatri

c H

emat

olog

y an

d O

ncol

ogy,

Uni

vers

ity C

hild

ren'

s H

ospi

tal,

D –

481

29 M

ünst

er

X =

Req

uire

d (X

) = If

indi

cate

d

GER

MIN

OM

A A

ND

NG

GC

T En

d of

Tr

eatm

ent (

6-12

wee

ks a

fter

EOT)

4 m

onth

s 8

mon

ths

12 m

onth

s (1

yea

r) 18

mon

ths

24 m

onth

s (2

yea

rs)

3 ye

ars

4

year

s

5 ye

ars

MR

I cra

nial

x

x x

x x

x x

x x

MR

I spi

nal

x P

erfo

rmed

bas

ed o

n sy

mpt

oms

or a

ccor

ding

to c

linic

ian’

s di

scre

tion,

but

at l

east

with

alte

rnat

e he

ad s

cans

in p

atie

nts

with

CN

S in

volv

emen

t of

thei

r tum

our a

t dia

gnos

is, a

ssum

ing

a cl

ear s

can

at th

e en

d of

trea

tmen

t. Tu

mou

r mar

ker

(AFP

+ to

tal H

CG

) G

erm

inom

a x

x x

x x

x x

x x

Tum

our m

arke

r (A

FP +

tota

l HC

G) N

GG

CT

x M

onth

ly fo

r the

1st y

ear

2 m

onth

ly fo

r the

2nd

yea

r 3

mon

thly

for

the

3rd y

ear

Qua

lity

of L

ife a

sses

smen

t (*

+ n

euro

cogn

itive

ass

essm

ent

whe

re p

erfo

rmed

) x

X*

x

Endo

crin

e ev

alua

tion

Oph

thal

mol

ogic

al a

sses

smen

t H

earin

g as

sess

men

t G

FR o

r cre

atin

ine

clea

ranc

e O

ther

ass

essm

ents

for

com

plic

atio

ns o

f tum

our a

nd

treat

men

t

Tim

ing

acco

rdin

g to

loca

l/nat

iona

l pra

ctic

e

inte

rnat

. tria

l no.

: └┴┴┴┘

cent

re n

o.:

└┴┴┘

trial

no.

: └┴┴┴┴┴┴┴┘

se

x:└┘

MM

DD

Y Y

Y Y

da

te o

f birt

h

SIO

P C

NS

GC

T II,

Fin

ale

Ver

sion

2, 1

5.06

.201

1, A

ppen

dix

C.6

S

eite

1 v

on 1


SIOP CNS GCT II, Finale Version 2, 15.06.2011, Appendix C. 7 Seite 1 von 2

SIOP CNS GCT II Time frame for return of documentation forms time point documentation form time frame for posting

obtain consent immediately registration fax as soon as possible but anyway

before start of chemotherapy (via fax)

operation note local histopathology

as soon as possible, preferably before start of chemotherapy

reference histopathology

as soon as possible

patient’s evaluation form (diagnostic and pre-treatment assessment)

as soon as possible

QoL CRFs Social and living inviroment

as soon as possible

diagnosis

Neurocognitve assessment

as soon as possible

chemotherapy forms including toxicity and response

after reevaluation

irradiation forms after first control after irradiation

therapy

Neurosurgery form After surgery Severe adverse event SAE-form Immediately (24 hours) via fax

medical letter as soon as possible end of therapy QoL CRFs as soon as possible

diagnosis of relapse event form as soon as possible, preferably before start of second line treatment

follow-up form once a year QoL CRFs 2 years and 5 years after treatment

follow-up

Neurocognitve assessment

2 years and 5 years after treatment

end of hospital follow-up

letter with address of the paediatrician / general practitioner

as soon as possible


SIOP CNS GCT II, Finale Version 2, 15.06.2011, Appendix C. 7 Seite 2 von 2

SIOP CNS GCT II Time frame for RDE time point RDE / paperform time frame for posting

obtain consent (paper) immediately Registration in RDE as soon as possible but anyway

before start of chemotherapy operation note (paper)local histopathology (paper)

as soon as possible, preferably before start of chemotherapy

reference histopathology (paper)

as soon as possible

patient’s evaluation in RDE (diagnostic and pre-treatment assessment)

as soon as possible

QoL CRFs (paper) Social and living inviroment

as soon as possible

diagnosis

Neurocognitve assessment (paper)

as soon as possible

chemotherapy in RDE including toxicity and response

While evaluation

irradiation forms (paper? Filled in from the radiologist)

after first control after irradiation

therapy

Neurosurgery form (paper ? filled in from the surgeon)

After surgery

Severe adverse event SAE-form Immediately (24 hours) via fax medical letter (paper) as soon as possible end of therapy QoL CRFs (paper) as soon as possible

diagnosis of relapse event form in RDE as soon as possible, preferably before start of second line treatment

follow-up form in RDE once a year QoL CRFs (paper) 2 years and 5 years after treatment

follow-up

Neurocognitve assessment (paper)

2 years and 5 years after treatment

end of hospital follow-up

letter with address of the paediatrician / general practitioner (paper)

as soon as possible


INITIAL ACTION IN INTRACRANIAL TUMORS · for teratoma modified according to treatment) Dr....

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Transcript of INITIAL ACTION IN INTRACRANIAL TUMORS · for teratoma modified according to treatment) Dr....