Övriga formulär

17
Patient Study No.
Chemoradiation form: Form C
To be completed as indicated below during chemoradiation.
Enter form data into the NeoRes database
Retain the copy for patient records.
Patients initials ________________
Baseline
End week 4
Date assessed
ECOG performance status
Weight (kgs)
Route(s) of nutrition
Toxicity (see reverse for coding)
Pharynx & oesophagus
Upper Gl
Lung
Skin
Mucous membranes
Lower Gl
Fever
Infection
Nausea & vomiting
Other acute chemoradiationrelated toxicity (specify type and
grade)
Haematology & Biochemistry (please enter actual values), Nadir
Date of test(s)
neutrophils (109/L)
Creatinine (mmol/L)
Hb
Tpk
End week 7
End week 10
NOTES - FORM C
Acute Radiation (and chemotherapy) Morbidity Scoring Criteria
(from RTOG/Dishe scoring system)
System
Grade 0
Grade 1
Grade 2
Grade 3
Grade 4
Pharynx &
oesophagus
No change
over
baseline
Mild dysphagia or
odynophagia. May
require topical
anaesthetic or nonnarcotic analgesics. May
require soft diet.
Moderate dysphagia or
odynophagia. May
require narcotic
analgesics. May require
puree or liquid diet.
Complete obstruction,
ulceration, perforation,
fistula.
Upper Gl
No change
Anorexia with < 5 %
weight loss from
pretreatment baseline.
Nausea not requiring
antiemetics. Abdominal
discomfort not requiring
parasympatholytic drugs
or analgesics.
Anorexia with < 15%
weight loss from
pretreatment baseline.
Nausea and/or vomiting
requiring antiemetics.
Abdominal pain
requiring analgesics.
Lung
No change
Mild symptoms of dry
cough or dyspnoea on
exertion.
Persistent cough
requiring narcotic
antitussive agents.
Dyspnoea with minimal
effort but not at rest.
Skin
No change
Mucous
membranes
No change
Follicular, faint or dull
erythema. Epilation. Dry
desquamation. Decreased
sweating.
Injection. May
experience mild pain not
requiring analgesics.
Severe dysphagia or
odynophagia with
dehydration or weight
loss (> 15 % from
pretreatment baseline)
requiring N-G feeding
tube I.V. fluids, or
hyperalimentation.
Anorexia with > 15 %
weight loss from
pretreatment baseline or
requiring N-G tube or
parenteral support.
Nausea and/or vomiting
requiring N-G tube or
parenteral support.
Abdominal pain, severe
despite medication.
Haematemesis or
melaena. Abdominal
distension (flat plate
radiograph demonstrates
distended bowel loops).
Severe cough
unresponsive to narcotic
antitussive agents or
dyspnoea at rest. Clinical
or radiologic evidence of
acute pneumonitis.
Intermittent O2 or
steroids may be required.
Confluent, moist
desquamation other than
skin folds, pitting
oedema.
Confluent fibrinous
mucositis. May include
severe pain requiring
narcotics.
Lower Gl
No change
Acute or subacute
obstruction, fistula or
perforation. Gl bleeding
requiring transfusion.
Abdominal pair or
tenesmus requiring tube
decompression or bowel
diversion.
Fever
Infection
Nausea &
vomiting
None
None
None
Diarrhoea requiring
parenteral support.
Severe mucous or bloody
discharge necessitating
sanitary pads.
Abdominal distension
(flat plate radiograph
demonstrates distended
bowel loops).
> 40.0oC
Bacteraemia.
Intractable vomiting, > 6
per day despite
medication.
Tender or bright
erythema. Patchy moist
desquamation. Moderate
oedema.
Patchy mucositis which
may produce an
inflammatory
serosanguinous
discharge. May
experience moderate
pain requiring
analgesics.
Increased frequency of
Diarrhoea requiring
defecation or change in
parasympatholytic drugs.
quality of bowel habits
Mucous discharge not
not requiring medication. necessitating sanitary
Rectal discomfort not
pads. Rectal or
requiring analgesics.
abdominal pain requiring
analgesics.
> 37.5 - 38.0oC
No active therapy
Nausea, no vomiting.
> 38.0oC
Requires active therapy.
Controllable, < 6 times
per day.
Ileus, subacute or acute
obstruction, perforation.
Gl bleeding requiring
transfusion. Abdominal
pain requiring tube
decompression or bowel
diversion.
Severe respiratory
insufficiency.
Continuous oxygen or
assisted ventilation.
Ulceration, haemorrhage,
necrosis.
Ulceration, haemorrhage,
or necrosis.
Fever with hypotension.
Life threatening.
Severe and continuous
vomiting. Requires
hospitalisation.
18
Patient Study No.
Summary of treatment form: Form D
To be completed after all planned chemoradiation has been given.
Enter form data into the NeoRes database
Retain the copy for patient records.
Patients initials ________________
RADIOTHERAPY SUMMARY
Yes No
1
Radiotherapy given? (Y/N).
If Yes, please complete Chemoradiation Form C also
Yes No
2
Radiotherapy given according to protocol? (Y/N)
If No, please specify reason and deviation
____________________________________________________________________
____________________________________________________________________
yy
mm
yy
mm
3
Date radiotherapy started
4
Date radiotherapy completed
5
Total tumour dose (Gy)
6
Number of fractions
7
Number of fields
dd
dd
CHEMOTHERAPY SUMMARY
Yes No
8
Chemotherapy given? (Y/N)
If Yes, please complete Chemoradiation form C also
Yes No
9
Chemotherapy given according to protocol? (Y/N)
If No, pleasy specify reason and deviation
____________________________________________________________________
____________________________________________________________________
.
10
11
12
BSA used for dose calculation
Total dose cisplatin received (mg)
Total dose 5-FU received (mg)
Version 4
date 2008-01-30
Preoperative histopathology report
Patient Study No.
Pat. initials…………..
Squamous cell carcinoma
a) High grade = 1
b) Intermediate grade = 2
c) Low grade = 3
Adenocarcinoma:
a) High grade = 1
b) Intermediate grade = 2
c) Low grade = 3
Other type (specify)
…………………………………………………………………………………
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
NEORES – PREOPERATIVA DATA
Personnr
ifylles innan op
Namn
Läkare
Klinik, sjukhus
Registreringsdatum
År
Mån
Ankomstdatum för remiss till
behandlande enhet
År
Dag
Mån
Enter form data into the NeoRes database.
Retain the copy for patient records.
Dag
PREOPERATIVA DATA
Diagnosdatum/
Datum för biopsi
År
Mån
PAD-nr från biopsi ___________________________ Patologlab _________________________________
Dag
Histologisk typ av tumör från biopsi _______________________________________________________
Diagnoskoder (ICD 10) v g se hjälpbild på baksidan för klassificering
Esofagus
Cardia
Ventrikel
C15.0 Cervikala esofagus
Typ I C16.0.A
C16.1 Fundus (övre delen)
C16.5 Curvatura minor UNS
C15.3 Övre tredjedelen av esofagus
Typ II C 16.0.B
C16.2 Corpus (mellersta delen)
C16.6 Curvatura major UNS
C15.4 Mellersta tredjedelen av esofagus
Typ III C 16.0.C
C16.3 Antrum (nedre delen)
C16.8 Multifokal lok
C15.5 Nedre tredjedelen av esofagus
Ej bestämbar
C 16.0.X
C16.4 Pylorus (nedre magmunnen)
C16.9 Magsäck UNS
C15.8 Multifokal lokalisation
C15.9 Matstrupen UNS
Preoperativ utredning av patienten
Preop TNM stadium
baserat på
Preoperativt T-stadium (tumörstadium)
Tis – Carcinoma in situ
T1 – Tumörinvasion till lamina propria eller submucosa
T2 – Tumörinvasion till muscularis propria
T3 – Tumörinvasion till serosa/adventitia
T4 – Överväxt på kringliggande organ
TX – Ej bedömt
Esofagogastroskopi
Kontraströntgen esofagus/ventrikel
CT
MR
PET
CT PET
Endoskopiskt ultraljud
Ultraljud
Bronkoskopi
Diagnostisk laparo-/thorakoskopi
Spirometri
Arbetsprov
Annat, specificera ___________________
Kommentar:
Preoperativt N och M - stadium (lymfkörtelstadium)
Preoperativt tumörpositiva lymfkörtelstationer Hals och Thorax
Ej bedömda
Inga
[1] Cervikala (Scalenus, v jugularis int, övre och nedre cervikala,
periesofageala, supraclavikulära)
[2] Paratrakeala
[3] Subcarinala
[4] Höger huvudbronk
[5] Vänster huvudbronk
[6] Paraesofageala – mellersta thorakala mediastinum
[7] Paraesofageala – nedre thorakala mediastinum
Preoperativt tumörpositiva lymfkörtelstationer Buk
Ej bedömda
[8] A hepatica
Inga
[9] Truncus coeliacus
[1] Cardia höger
[10] Mjälthilus
[2] Cardia vänster
[11] A lienalis
[3] Curvatura minor
[12] Hepatoduodenala lig
[4] Curvatura major
[13] Posteriora pancreashuvudet
[5] Suprapylorala
[14] Mesenterialkärlsroten
[6] Infrapylorala
[15] Mesocolon transversum
[7] A gastrica sin
[16] Paraaortala
Fjärrmetastasering:
Lungmetastasering
Levermetastasering
Pleuracarcinomatos
Preoperativ radioterapi
Nej
Ja
Bukcarcinos
Annat:
Preoperativ kemoterapi
Preoperativt TNM stadium ____________________________________ (se baksida)
Nej
Ja
NEORES – OPERATIONSDATA
ifylles samma dag pat opererats
Läkare
Registreringsdatum
År
Mån
Dag
Patient Study No.
OPERATIONSDATA
År
Mån
Dag
Op datum
Op koder: ____________________________________________________________________
Sammanfattande namn på ingreppet ____________________________________________________________________________________
Op start ___________________ Op slut __________________________
(datum, kl)
Preoperativ vikt ________ kg Längd ____________ cm
Resektion av tumören
Elektiv op
Akut op
Op blödning ____________ ml
(datum, kl)
Nej (enbart Alt 1 nedan fylls i)
ASA klass __________________
Ja (enbart Alt 2 nedan fylls i)
Alt 1. Resektion=Nej
Palliativ(a) åtgärd(er) en eller flera
Ingen åtgärd (utöver morfin etc)
Explorativ laparotomi
Gastroenteroanastomos
Gastrostomi vid laparotomi
Nutritiv jejunostomi
Explorativ thorakotomi
Subcutan venport (PAC)
Perkutan endoskopisk gastrostomi (PEG)
Laserbehandling/Argonplasmabehandling
Stent
Annan endoskopisk palliativ terapi
Palliativ radioterapi
Palliativ kemoterapi
Endoluminal strålterapi (brachyterapi)
Annat, specificera ______________________________________
Om ingen tumörresektion utförts är blanketten färdigifylld och kan sändas in. Alt 2 nedan behöver ej fyllas i.
Alt 2. Resektion=Ja
Kurativt syftande dissektion med makroskopiskt avlägsnad tumör
Operationsbeskrivning thorax
Ingen thoraxdissektion
Högersidig thorakotomi
(anterior, anterolateral, posterolateral, posterior)
Vänstersidig thorakotomi
(anterior, anterolateral, posterolateral, posterior)
Kombinerat sammanhängande thorakoabdominellt snitt
Transhiatal op utan thorakotomi
Substernal op utan thorakotomi
Thorakoskopisk
Annan, specificera
Esofagusresektion
Ingen
Intraabdominella
Distala intrathorakala 1/3 upp till nivå med nedre lungvenen
Distala intrathorakala 2/3 upp till nivå med tracheabifurkationen/v azygos
Hela intrathorakala
Utrymda lymfkörtelstationer hals och thorax
Ingen lymfkörtelutrymning
[1] Cervikala (Scalenus, v jugularis int, övre och nedre cervikala,
periesofageala, supraclavikulära)
[2] Paratrakeala
[3] Subcarinala
[4] Höger huvudbronk
[5] Vänster huvudbronk
[6] Paraesofageala – mellersta thorakala mediastinum
[7] Paraesofageala – nedre thorakala mediastinum
Nej
Ja
Operationsbeskrivning hals
Ingen halsincision
Halsincision hö
Halsincision vä
Annat specificera
Cervikala
Cervikala + intrathorakala
Lokal excision av esofagus
Endoskopisk esofagusresektion
forts. Alt 2. Resektion=Ja
Ventrikelresektion
Ingen
Distala
Distala samt mellersta
Hela
Proximala
Proximala och mellersta
Minorsidan
Endoskopisk ventrikelexcision
Lokal excision av ventrikel
Utrymda lymfkörtelstationer buk
Ingen lymfkörtelutrymn
[9] Truncus coeliacus
[1] Cardia höger
[10] Mjälthilus
[2] Cardia vänster
[11] A lienalis
[3] Curvatura minor
[12] Hepatoduodenala lig
[4] Curvatura major
[13] Posteriora pancreashuvudet
[5] Suprapylorala
[14] Mesenterialkärlsroten
[6] Infrapylorala
[15] Mesocolon transversum
[7] A gastrica sin
[16] Paraaortala
[8] A hepatica
Ytterligare resektion
Ingen
Mjältexstirpation
Pancreasresektion
Colonresektion
Leverresektion
Diafragmaresektion
Resektion av ductus thoracicus
Resektion av vena azygos
Lungresektion
Perikardresektion
Larynxresektion
Övrig resektion ________________________________
Rekonstruktion
Ingen (inkl blind slutning, framläggning av faryngostomi el annan stomi till hud
då den gastrointestinala kontinuiteten ej återställs)
Distal ventrikelresektion med gastroduodenostomi (BI)
Ventrikelresektion med gastrojejunostomi och enteroanastomos (BII)
Ventrikelresektion med gastrojejunostomi utan enteroanastomos (BII)
Roux-en-Y esofagojejunostomi
Roux-en-Y esofagojejunostomi med reservoar
Tunntarmsinterposition (från esofagus till ventrikel eller duodenum)
Interponerad tunntarmsreservoar (esofagus till duodenum)
Interponerad colonreservoar (esofagus till duodenum)
Ventrikeltub till esofagus
Ventrikel till esofagus
Coloninterposition (esofagus till ventrikel eller duodenum)
Kommentarer: ____________________________________ Bursektomi
Suturteknik anastomos
(vid flera anastomoser anges den mest proximala)
Handsydd
Suturmaskin
Nej
Ja
Omentektomi
Nej
Anastomosnivå
Buk
Hiatus
Nedre lungvenen
Ja
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
Vena azygos/tracheabifurkationen
Pleuratopp
Hals
NEORES–VÅRDDATA/KOMPLIKATIONER
ifylles i anslutning till 1 månadskontrollen postoperativt
Läkare
Klinik, sjukhus
Patient Study No.
VÅRDDATA SAMT KOMPLIKATIONER
År
Mån
Dag
Utskriven till
Utskrivningsdatum efter op
Fortsatt onkologisk terapi
Ingen
Kurativt syftande terapi
Palliativ terapi
Hemmet
Annan kir klin, vilken __________________________________
Annan klinik inkl rehabklinik
Sjukhem
Övrig konvalescens
Kirurgiska komplikationer inom 30 dagar efter huvudoperationen
Ingen komplikation
Blödning
Reoperation
Konservativ behandling
Anastomosinsufficiens
Öppen reop
Konservativ behandling med antibiotika samt ev perkutant dränage
Stentbehandling
Nej
Ja
Öppen reop
Konservativ behandling med antibiotika samt ev perkutant dränage
Nej
Ja
Stentbehandling
Substitutnekros
Intraabdominell abscess
Öppen reop
Konservativ behandling med antibiotika samt ev perkutant dränage
Intrathorakal abscess
Öppen reop
Konservativ behandling med antibiotika samt ev perkutant dränage
Ductus thoracicusskada
Öppen reop
Konservativ behandling
Nervus recurrens pares
Annan svår vårdförlängande komplikation
(>7 dagar förväntad normal vårdtid)
Beskrivning _______________________________________________________________
Med operation
Utan operation
Allmänna komplikationer inom 30 dagar efter huvudoperationen
Ingen komplikation
Allvarlig pneumoni
Sepsis
Med operation
Allvarlig cardiovaskulär komplikation
Utan operation
(ex nydebuterad rytmrubbning som krävt behandling, hjärtinfarkt, stroke)
Lungemboli
Annan svår vårdförlängande komplikation
(>7 dagar förväntad normal vårdtid)
Beskrivning _______________________________________________________________
Med operation
Utan operation
PAD
PAD nr från op preparat ________________________________ Patologlab _____________________________________________________
Histologisk typ av tumör från op preparat _________________________________________________________________________________
Mikroskopisk radikalitet
Proximalt
Nej
Ja
Antal borttagna lymfkörtlar: ___________________
Distalt
Nej
Ja
Antal tumörpositiva lymfkörtlar ________________
Cirkulärt
Nej
Ja
pTNM Stadium _____________________________
Kommentarer:
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
Version 4
date 2008-01-30
Postoperative histopathology report:
Patient Study No.
initials…………..
Macroscopic evaluation of tumour growth:
Circumferential extent
Not visible = 1
< 25 % of the circumference = 2
>25 % of the circumference but < 75 % = 3
>75 – circumferential growth = 4
Longitudinal extent (cm)
pT status (1-4)
pN1 status (0-1)
pN2 status (0-1)
Proximal resection margin
Free from residual tumor = 1
Distal resection margin
Free from residual tumor = 1
Circumferential resection margin
Free from residual tumor = 1
Squamous cell carcinoma
a) High grade = 1
b) Intermediate grade = 2
c) Low grade = 3
Version 4
date 2008-01-30
Adenocarcinoma:
a) High grade = 1
b) Intermediate grade = 2
a) Low grade = 3
Other type (specify)
…………………………………………………………………………………
Tumour stage according to histopatological findings in the operative specimen
T-stage
T1
T2
T3
T4
N-stage
N0
N1
M-stage
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
M0
M1
Version 4
date 2008-01-30
Patient Study No.
ESOPHAGEAL STUDY
Follow-up form: Form G
To be completed three months after randomisation, and at death.
Enter form data into the NeoRes database
Retain the copy for patient records.
Patients initials ________________
1
yy
mm
2
Date of follow-up
dd
Patient status
1 = alive, disease-free (complete follow-up details box only)
2 = alive, with disease (complete relapse box if first notification of relapse, and follow-up details box)
3 = dead (complete death details box and all relevant qeustions in follow-up box)
9 = unknown
12
Optional information
3
,
Length (cm)
,
Weight (kg)
Any anti-tumour treatment since last
follow-up? (Y/N). If Yes:
 Chemotherapy (specify drugs)
_________________________________________
 Radiation therapy (specify site)
_________________________________________
 Surgery (specify type)
_________________________________________
 Other (specify)
_________________________________________
Yes No
4
Oesophageal dilation required
since last follow-up? (Y/N)
5
Gastrostomy required since last
follow-up?(Y/N)
Yes No
NUTRITION (optional)
6
Route of nutrition
(one or several of the following)
 Oral
 Enteral (type .....................................
...........................................................)
 Parenteral
13
DEATH DETAILS
7
yy
mm
8
Date of death
dd
Death related to
1 = tumour
2= tumour and treatment
3 = other cause (specify)
9 = unknown
__________________________________
Please attach copy of autopsy
report if available
14
EXTRA Visit (t = …. months)
Patient Study No.
Date (day-month-year)
Body weight (kg)
Dysphagia score (0-4)
(0 = no dysphagia; 1 = some dysphagia, but no dietary limitations; 2 = can drink,
but only eat semisolid food; 3 = can only drink; 4 = total dysphagia)
Enteral nutritional support (yes =1)
Parenteral nutritional support (yes =1)
Performance status
EORTC QLQ,C-30: OES 24
Toxicity (see separate form)
Disease free (yes=1)
Recurrence (yes=1)
If yes, specify:
a) Mediastinal = 1
b) Anastomotic = 2
c) Extrathroacic = 3
d) Mutiple locations = 4
Yes =1 , No= 2
15
Abdominal CT scan:
Performed
Not performed
No signs of metastatic disease
Signs of metastatic
disease
Please specify:
Thoracic CT scan:
Performed
No signs of metastatic disease
Not performed
Signs of metastatic disease
Please specify:
Endoscopic ultrasound:
No signs of metastatic disease
Please specify:
Performed
Not performed
Signs of metastatic disease
16
PET-CT scan:
Performed
No signs of metastatic disease
Not performed
Signs of metastatic disease
Please specify:
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
17
Version 4
date 2008-01-30
Visit 1 (t = 3 months)
Patient Study No.
Date of visit:
year………month…day…………..
Physical examination
Weight
______ kg
Normal
Abnormal
Specification of abnormalities
Performance status
0-4
Heart
Lungs
Lymph nodes
Abdomen
Has the patient been found to have a recurrence of esophagocardia cancer
since last visit?
Yes
Please fill out
Recurrence of cancer”
No
18
Version 4
date 2008-01-30
Has the patient had any alarm symptoms such as jaundice, anorexia, accelerating
abdominal pain, vomiting or any abnormal findings in physical examination or
laboratory assessments indicating recurrence of cancer?
Yes
No
Please specify symptoms / findings and action taken.
Dysphagia score (0-4)
(0 = no dysphagia; 1 = some dysphagia, but no dietary limitations; 2 = can drink,
but only eat semisolid food; 3 = can only drink; 4 = total dysphagia)
Enteral nutritional support (yes =1)
Parenteral nutritional support (yes =1)
Performance status
EORTC QLQ,C-30: OES 18
Yes =1 , No= 2
Toxicity (see separate form)
Disease free (yes=1)
Recurrence (yes=1)
If yes, specify:
a) Mediastinal = 1
b) Anastomotic = 2
c) Extrathroacic = 3
d) Mutiple locations = 4
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
19
Version 4
date 2008-01-30
Patient Study No.
Visit 2 (t = 6 months)
Date of visit:
year………month…day…………..
Physical examination
Weight
______ kg
Normal
Abnormal
Specification of abnormalities
Performance status
0-4
Heart
Lungs
Lymph nodes
Abdomen
Has the patient been diagnosed with a recurrence of esophagocardia cancer
since last visit?
Yes
No
Please fill out ”
Recurence of cancer”
Has the patient had any alarm symptoms such as jaundice, anorexia, accelerating
abdominal pain, vomiting or any abnormal findings in physical examination or
laboratory assessments indicating recurrence of cancer?
Yes
Please specify symptoms / findings and action taken.
No
20
Dysphagia score (0-4)
(0 = no dysphagia; 1 = some dysphagia, but no dietary limitations; 2 = can drink,
but only eat semisolid food; 3 = can only drink; 4 = total dysphagia)
Enteral nutritional support (yes =1)
Parenteral nutritional support (yes =1)
Performance status
EORTC QLQ,C-30: OES 18
Yes =1 , No= 2
Toxicity (see separate form)
Disease free (yes=1)
Recurrence (yes=1)
If yes, specify:
a) Mediastinal = 1
b) Anastomotic = 2
c) Extrathroacic = 3
d) Mutiple locations = 4
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
21
Version 4
date 2008-01-30
Patient Study No.
Visit 3 (t = 9 months)
year………month…day…………..
Date of visit:
Physical examination
Weight
______ kg
Normal
Abnorma Specification of abnormalities
l
Performance status
0-4
Heart
Lungs
Lymph nodes
Abdomen
Has the patient been diagnosed with a recurrence of esophagocardia cancer
since last visit?
Yes
Please fill out ”
Recurence of cancer”
No
22
Version 4
date 2008-01-30
Has the patient had any alarm symptoms such as jaundice, anorexia, accelerating
abdominal pain, vomiting or any abnormal findings in physical examination or
laboratory assessments indicating recurrence of cancer?
Yes
No
Please specify symptoms / findings and action taken.
Dysphagia score (0-4)
(0 = no dysphagia; 1 = some dysphagia, but no dietary limitations; 2 = can drink,
but only eat semisolid food; 3 = can only drink; 4 = total dysphagia)
Enteral nutritional support (yes =1)
Parenteral nutritional support (yes =1)
Performance status
EORTC QLQ,C-30: OES 18
Yes =1 , No= 2
Toxicity (see separate form)
Disease free (yes=1)
Recurrence (yes=1)
If yes, specify:
a) Mediastinal = 1
b) Anastomotic = 2
c) Extrathroacic = 3
d) Mutiple locations = 4
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
23
Version 4
date 2008-01-30
Visit 4 (t = 12 months)
Patient Study No.
year………month…day…………..
Date of visit:
Physical examination
Weight
______ kg
Normal
Abnormal
Specification of abnormalities
Performance status
0-4
Heart
Lungs
Lymph nodes
Abdomen
Has the patient been diagnosed with a recurrence of esophagocardia cancer
since last visit?
Yes
Please fill out ”
Recurrence of cancer”
No
24
Version 4
date 2008-01-30
Has the patient had any alarm symptoms such as jaundice, anorexia, accelerating abdominal
pain, vomiting or any abnormal findings in physical examination or laboratory assessments
indicating recurrence of cancer?
Yes
No
Please specify symptoms / findings and action taken.
Dysphagia score (0-4)
(0 = no dysphagia; 1 = some dysphagia, but no dietary limitations; 2 = can drink,
but only eat semisolid food; 3 = can only drink; 4 = total dysphagia)
Enteral nutritional support (yes =1)
Parenteral nutritional support (yes =1)
Performance status
EORTC QLQ,C-30: OES 18
Yes =1 , No= 2
Toxicity (see separate form)
Disease free (yes=1)
Recurrence (yes=1)
If yes, specify:
a) Mediastinal = 1
b) Anastomotic = 2
c) Extrathroacic = 3
d) Mutiple locations = 4
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
25
Version 4
date 2008-01-30
Visit 5 (t = 18 months)
Patient Study No.
year………month…day…………..
Date of visit:
Physical examination
Weight
______ kg
Normal
Abnormal
Specification of abnormalities
Performance status
0-4
Heart
Lungs
Lymph nodes
Abdomen
Has the patient been diagnosed with a recurrence of esophagocardia cancer
since last visit?
Yes
No
Please fill out ”
Recurrence of cancer”
Has the patient had any alarm symptoms such as jaundice, anorexia, accelerating
abdominal pain, vomiting or any abnormal findings in physical examination or
laboratory assessments indicating recurrence of cancer?
Yes
Please specify symptoms / findings and action taken.
No
26
Version 4
date 2008-01-30
Dysphagia score (0-4)
(0 = no dysphagia; 1 = some dysphagia, but no dietary limitations; 2 = can drink,
but only eat semisolid food; 3 = can only drink; 4 = total dysphagia)
Enteral nutritional support (yes =1)
Parenteral nutritional support (yes =1)
Performance status
EORTC QLQ,C-30: OES 18
Yes =1 , No= 2
Toxicity (see separate form)
Disease free (yes=1)
Recurrence (yes=1)
If yes, specify:
a) Mediastinal = 1
b) Anastomotic = 2
c) Extrathroacic = 3
d) Mutiple locations = 4
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
27
Version 4
date 2008-01-30
Visit 6 (t =24 months)
Patient Study No.
year………month…day…………..
Date of visit:
Physical examination
Weight
______ kg
Normal
Abnormal
Specification of abnormalities
Performance status
0-4
Heart
Lungs
Lymph nodes
Abdomen
Has the patient been diagnosed with a recurrence of esophagocardia cancer
since last visit?
Yes
No
Please fill out ”
Recurrence of cancer”
Has the patient had any alarm symptoms such as jaundice, anorexia, accelerating
abdominal pain, vomiting or any abnormal findings in physical examination or
laboratory assessments indicating recurrence of cancer?
Yes
Please specify symptoms / findings and action taken.
No
28
Version 4
date 2008-01-30
Dysphagia score (0-4)
(0 = no dysphagia; 1 = some dysphagia, but no dietary limitations; 2 = can drink,
but only eat semisolid food; 3 = can only drink; 4 = total dysphagia)
Enteral nutritional support (yes =1)
Parenteral nutritional support (yes =1)
Performance status
EORTC QLQ,C-30: OES 18
Yes =1 , No= 2
Toxicity (see separate form)
Disease free (yes=1)
Recurrence (yes=1)
If yes, specify:
a) Mediastinal = 1
b) Anastomotic = 2
c) Extrathroacic = 3
d) Mutiple locations = 4
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
29
Version 4
date 2008-01-30
Visit 7 (t = 36 months)
Patient Study No.
year………month…day…………..
Date of visit:
Physical examination
Weight
______ kg
Normal
Abnormal
Specification of abnormalities
Performance status
0-4
Heart
Lungs
Lymph nodes
Abdomen
Has the patient been diagnosed with a recurrence of esophagocardia cancer
since last visit?
Yes
No
Please fill out ”
Recurrence of cancer”
Has the patient had any alarm symptoms such as jaundice, anorexia, accelerating
abdominal pain, vomiting or any abnormal findings in physical examination or
laboratory assessments indicating recurrence of cancer?
Yes
Please specify symptoms / findings and action taken.
No
30
Version 4
date 2008-01-30
Dysphagia score (0-4)
(0 = no dysphagia; 1 = some dysphagia, but no dietary limitations; 2 = can drink,
but only eat semisolid food; 3 = can only drink; 4 = total dysphagia)
Enteral nutritional support (yes =1)
Parenteral nutritional support (yes =1)
Performance status
EORTC QLQ,C-30: OES 18
Yes =1 , No= 2
Toxicity (see separate form)
Disease free (yes=1)
Recurrence (yes=1)
If yes, specify:
a) Mediastinal = 1
b) Anastomotic = 2
c) Extrathroacic = 3
d) Mutiple locations = 4
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
31
Version 4
date 2008-01-30
DOSE LIMITING TOXICITY
Center
Pat. number
Pat. initials
Please complete this form and fax it to , KI , ?
Fax nr (+46), within 3 days of the event.
Please specify below what kind of side-effect accord.
SIDE EFFECTS (according to NCI CTC criteria)
1 2
Fluid retention
0
1 2 3
Hand-foot syndrome
0
1 2 3 4
Febrile neutropenia
0
1 2 3 4
Neuropathy
0
1 2 3 4
Other (specify)
0
1 2 3 4
Other (specify)
0
Alopecia
0
1 2 3 4
Dose Nausea
0
1 2 3
Limiti Vomiting
0
1 2 3 4
ng
Diarrhea
0
1 2 3 4
Toxic Stomatitis
0
1 2 3 4
ity
Infection
0
1 2 3 4
(DLT
) is defined as grade 2-3 hand-foot syndrome and /or any
grade 3-4 tocicity according to NCI
CTC criteria occuring within the first two cycles of the study.
Investigators signature
Date
(yy-mm-dd)
Signature of person completing the form
Date
(yy-mm-dd)
Telephone number: 0046 8 51772981 Fax number: 0046 851775444
32
Version 4
date 2008-01-30
20
Patient Study No.
ESOPHAGEAL STUDY
Follow-up form: Form G
To be completed three months after randomisation, and at death.
Enter form data into the NeoRes database
Retain the copy for patient records.
Patients initials ________________
1
yy
mm
2
Date of follow-up
dd
Patient status
1 = alive, disease-free (complete follow-up details box only)
2 = alive, with disease (complete relapse box if first notification of relapse, and follow-up details box)
3 = dead (complete death details box and all relevant qeustions in follow-up box)
9 = unknown
33
Optional information
3
,
Length (cm)
,
Weight (kg)
Any anti-tumour treatment since last
follow-up? (Y/N). If Yes:
 Chemotherapy (specify drugs)
_________________________________________
 Radiation therapy (specify site)
_________________________________________
 Surgery (specify type)
_________________________________________
 Other (specify)
_________________________________________
Yes No
4
Oesophageal dilation required
since last follow-up? (Y/N)
5
Gastrostomy required since last
follow-up?(Y/N)
Yes No
NUTRITION (optional)
6
Route of nutrition
(one or several of the following)
 Oral
 Enteral (type .....................................
...........................................................)
 Parenteral
34
DEATH DETAILS
7
yy
mm
8
Date of death
dd
Death related to
1 = tumour
2= tumour and treatment
3 = other cause (specify)
9 = unknown
__________________________________
Please attach copy of autopsy
report if available
35