ID

13407

Beschreibung

Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

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  1. 11.02.16 11.02.16 -
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11. Februar 2016

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Visit 2 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv

Englisch

Case report form (HIPEC) Visit 2

1 Formulare  
Patient Identification
Beschreibung

Patient Identification

Patient number
Beschreibung

Patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
CRF number
Beschreibung

CRF number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C0449788
Date of visit
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Debulking surgery
Beschreibung

Debulking surgery

Date of surgery
Beschreibung

Surgery date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Please give the time the surgery procedure started
Beschreibung

Surgery Start time

Datentyp

time

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2114713
Please give the time the surgical procedure was completed
Beschreibung

Surgery end time

Datentyp

time

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2711097
Time from incision to suture
Beschreibung

Time from incision to suture

Datentyp

float

Maßeinheiten
  • Minutes
Alias
UMLS CUI [1,1]
C2116297
UMLS CUI [1,2]
C0009068
Minutes
Type of surgery:Hysterectomy
Beschreibung

Hysterectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0020699
Type of surgery:unilateral salpingo-oophorectomy
Beschreibung

Salpingo-oophorectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0041692
Type of surgery:bilateral salpingectomy with oophorectomy
Beschreibung

Salpingo-oophorectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0195495
Type of surgery: Right hemicolectomy
Beschreibung

Right hemicolectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0192861
Type of surgery:Transverse colectomy
Beschreibung

Transverse colectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0192863
Type of surgery: left colectomy
Beschreibung

Left colectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0192865
Type of surgery: Stripping of pelvic peritoneum
Beschreibung

Stripping of pelvic peritoneum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0230295
UMLS CUI [1,2]
C0185047
Type of surgery: Excision of periaortic lymph nodes
Beschreibung

Excision of periaortic lymph nodes

Datentyp

boolean

Alias
UMLS CUI [1]
C0193874
Type of surgery: Appendectomy
Beschreibung

Appendectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0003611
Type of surgery:Splenectomy
Beschreibung

Splenectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0037995
Type of surgery: Rectosigmoidectomy
Beschreibung

Rectosigmoidectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0193063
Type of surgery: Colostomy Procedure
Beschreibung

Colostomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0009410
Type of surgery: Resection of small intestines
Beschreibung

Resection of small intestines

Datentyp

boolean

Alias
UMLS CUI [1]
C0192571
Type of surgery: Diaphragm stripping
Beschreibung

Diaphragm stripping

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0198438
UMLS CUI [1,2]
C0185047
Type of surgery: supracolic omentectomy
Beschreibung

Omentectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0198614
UMLS CUI [1,2]
C0446612
Type of surgery:infracolic omentectomy
Beschreibung

Omentectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0456314
Type of surgery:Complete pelvic lymph node excision
Beschreibung

Pelvic lymph node excision

Datentyp

boolean

Alias
UMLS CUI [1]
C0398429
Type of surgery:Sampling of lymph node
Beschreibung

Lymph node sampling

Datentyp

boolean

Alias
UMLS CUI [1]
C0398417
Please specifiy any other type of surgery performed
Beschreibung

Other surgery

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0543467
Was there a residue after surgery?
Beschreibung

Residual tumor

Datentyp

text

Alias
UMLS CUI [1]
C0543478
Outcome of surgery and HIPEC
Beschreibung

Surgery outcome

Datentyp

text

Alias
UMLS CUI [1]
C0184788
Please specify any complications during surgery and HIPEC such as: i.e adhesions
Beschreibung

Surgery outcome

Datentyp

text

Alias
UMLS CUI [1]
C0184788
Biopsy sample of tumor tissue collected (separate consent required)
Beschreibung

Tumor biopsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0677862
HIPEC
Beschreibung

HIPEC

Has the HIPEC Procedure been performed? If "No", please specify the reason why below.
Beschreibung

Procedure performed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0884358
Please specify the reason why the HIPEC-Procedure has not been performed
Beschreibung

Procedure not performed

Datentyp

text

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0445106
Date the HIPEC-Procedure has been performed
Beschreibung

Procedure date

Datentyp

date

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0011008
Time procedure was started
Beschreibung

Procedure Start time

Datentyp

time

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1301880
Time procedure was completed
Beschreibung

Procedure end time

Datentyp

time

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1522314
Used dose in planned escalation scheme
Beschreibung

Dose escalation

Datentyp

text

Alias
UMLS CUI [1]
C3816728
Total dose applied (calculated from dose in mg multiplicated with body surface in square meter)
Beschreibung

Dose escalation

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1]
C3816728
mg
Was there a reaction during application? If "yes", please fill in AE form
Beschreibung

Reaction

Datentyp

boolean

Alias
UMLS CUI [1]
C0443286
Please give the total volume applied during perfusion
Beschreibung

Total volume applied

Datentyp

integer

Maßeinheiten
  • ml
Alias
UMLS CUI [1]
C2826310
ml
Please specify any particularities occurred during HIPEC Procedure
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Pharmacokinetics
Beschreibung

Pharmacokinetics

Blood sampling to validate concentration of cisplatin (ng/ml)
Beschreibung

Blood sampling

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Measuring point (from start of perfusion)
Beschreibung

Measuring point

Datentyp

text

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C1442880
Measuring point valid?
Beschreibung

Measuring point

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C1442880
Concentration of Cisplatin
Beschreibung

Concentration of Cisplatin

Datentyp

text

Maßeinheiten
  • ng/ml
Alias
UMLS CUI [1]
C0365714
ng/ml
Comments on any particularities during blood sampling and testing. Please specify measuring point
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Sample of perfusate taken?
Beschreibung

Sample of perfusate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0029704
Measuring point (from start of perfusion)
Beschreibung

Measuring point

Datentyp

text

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C1442880
Measuring point valid?
Beschreibung

Measuring point

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C1442880
Concentration of Cisplatin
Beschreibung

Concentration of Cisplatin

Datentyp

text

Maßeinheiten
  • ng/ml
Alias
UMLS CUI [1]
C0365714
ng/ml
Comments on any particularities during perfusate sampling and testing. Please specify measuring point
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Recording of CTCAE: Have any AE occurred perioperative or since the last Visit? If "Yes" please fill in AE-Form
Beschreibung

CTCAE

Datentyp

boolean

Alias
UMLS CUI [1]
C1516728
Has concomitant medication been subject to change? If "Yes" please fill in Concomitant medication form.
Beschreibung

Concomitant agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Confirmation of correctness
Beschreibung

Confirmation of correctness

Confirmatin of investigator: I hereby confirm that I personally checked this CRF for completeness and correctness. All data and statements in this CRF are ,according to best knowlwdge ,complete and correct.
Beschreibung

Confirmation

Datentyp

boolean

Alias
UMLS CUI [1]
C0750484
Name of Investigator
Beschreibung

Name of Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Signature of investigator
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Date of completion of this form
Beschreibung

Date of completion

Datentyp

date

Alias
UMLS CUI [1]
C0011008
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Ähnliche Modelle

Case report form (HIPEC) Visit 2

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Identification
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
CRF number
Item
CRF number
integer
C1516308 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Item Group
Debulking surgery
Surgery date
Item
Date of surgery
date
C0011008 (UMLS CUI [1])
Surgery Start time
Item
Please give the time the surgery procedure started
time
C0543467 (UMLS CUI [1,1])
C2114713 (UMLS CUI [1,2])
Surgery end time
Item
Please give the time the surgical procedure was completed
time
C0543467 (UMLS CUI [1,1])
C2711097 (UMLS CUI [1,2])
Time from incision to suture
Item
Time from incision to suture
float
C2116297 (UMLS CUI [1,1])
C0009068 (UMLS CUI [1,2])
Hysterectomy
Item
Type of surgery:Hysterectomy
boolean
C0020699 (UMLS CUI [1])
Salpingo-oophorectomy
Item
Type of surgery:unilateral salpingo-oophorectomy
boolean
C0041692 (UMLS CUI [1])
Salpingo-oophorectomy
Item
Type of surgery:bilateral salpingectomy with oophorectomy
boolean
C0195495 (UMLS CUI [1])
Right hemicolectomy
Item
Type of surgery: Right hemicolectomy
boolean
C0192861 (UMLS CUI [1])
Transverse colectomy
Item
Type of surgery:Transverse colectomy
boolean
C0192863 (UMLS CUI [1])
Left colectomy
Item
Type of surgery: left colectomy
boolean
C0192865 (UMLS CUI [1])
Stripping of pelvic peritoneum
Item
Type of surgery: Stripping of pelvic peritoneum
boolean
C0230295 (UMLS CUI [1,1])
C0185047 (UMLS CUI [1,2])
Excision of periaortic lymph nodes
Item
Type of surgery: Excision of periaortic lymph nodes
boolean
C0193874 (UMLS CUI [1])
Appendectomy
Item
Type of surgery: Appendectomy
boolean
C0003611 (UMLS CUI [1])
Splenectomy
Item
Type of surgery:Splenectomy
boolean
C0037995 (UMLS CUI [1])
Rectosigmoidectomy
Item
Type of surgery: Rectosigmoidectomy
boolean
C0193063 (UMLS CUI [1])
Colostomy
Item
Type of surgery: Colostomy Procedure
boolean
C0009410 (UMLS CUI [1])
Resection of small intestines
Item
Type of surgery: Resection of small intestines
boolean
C0192571 (UMLS CUI [1])
Diaphragm stripping
Item
Type of surgery: Diaphragm stripping
boolean
C0198438 (UMLS CUI [1,1])
C0185047 (UMLS CUI [1,2])
Omentectomy
Item
Type of surgery: supracolic omentectomy
boolean
C0198614 (UMLS CUI [1,1])
C0446612 (UMLS CUI [1,2])
Omentectomy
Item
Type of surgery:infracolic omentectomy
boolean
C0456314 (UMLS CUI [1])
Pelvic lymph node excision
Item
Type of surgery:Complete pelvic lymph node excision
boolean
C0398429 (UMLS CUI [1])
Lymph node sampling
Item
Type of surgery:Sampling of lymph node
boolean
C0398417 (UMLS CUI [1])
Other surgery
Item
Please specifiy any other type of surgery performed
text
C0205394 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item
Was there a residue after surgery?
text
C0543478 (UMLS CUI [1])
Residual tumor
Code List
Was there a residue after surgery?
CL Item
makroscopic no residue (0)
CL Item
<1cm residual tumor  (1)
CL Item
≥1cm residual tumor (2)
Item
Outcome of surgery and HIPEC
text
C0184788 (UMLS CUI [1])
Surgery outcome
Code List
Outcome of surgery and HIPEC
CL Item
without complications (1)
CL Item
with complications (Please fill in AE-Form and specify complications below) (2)
Surgery outcome
Item
Please specify any complications during surgery and HIPEC such as: i.e adhesions
text
C0184788 (UMLS CUI [1])
Tumor biopsy
Item
Biopsy sample of tumor tissue collected (separate consent required)
boolean
C0677862 (UMLS CUI [1])
Item Group
HIPEC
Procedure performed
Item
Has the HIPEC Procedure been performed? If "No", please specify the reason why below.
boolean
C0184661 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Procedure not performed
Item
Please specify the reason why the HIPEC-Procedure has not been performed
text
C0184661 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
Procedure date
Item
Date the HIPEC-Procedure has been performed
date
C0184661 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Procedure Start time
Item
Time procedure was started
time
C0184661 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Procedure end time
Item
Time procedure was completed
time
C0184661 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Used dose in planned escalation scheme
text
C3816728 (UMLS CUI [1])
Dose escalation
Code List
Used dose in planned escalation scheme
CL Item
I/I 60mg/sqm (1)
CL Item
II/II 80mg/sqm (2)
CL Item
III/III 100mg/sqm (3)
Dose escalation
Item
Total dose applied (calculated from dose in mg multiplicated with body surface in square meter)
integer
C3816728 (UMLS CUI [1])
Reaction
Item
Was there a reaction during application? If "yes", please fill in AE form
boolean
C0443286 (UMLS CUI [1])
Total volume applied
Item
Please give the total volume applied during perfusion
integer
C2826310 (UMLS CUI [1])
Comments
Item
Please specify any particularities occurred during HIPEC Procedure
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetics
Blood sampling
Item
Blood sampling to validate concentration of cisplatin (ng/ml)
boolean
C0005834 (UMLS CUI [1])
Item
Measuring point (from start of perfusion)
text
C0242485 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
Measuring point
Code List
Measuring point (from start of perfusion)
CL Item
0min (before application of chemo) (1)
CL Item
15min (2)
CL Item
30min (3)
CL Item
45min (4)
CL Item
60min (5)
CL Item
75min (6)
CL Item
90min (7)
CL Item
3h (8)
CL Item
6h (9)
CL Item
12h (10)
CL Item
18h (11)
CL Item
24h (12)
Measuring point
Item
Measuring point valid?
boolean
C0242485 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
Concentration of Cisplatin
Item
Concentration of Cisplatin
text
C0365714 (UMLS CUI [1])
Comments
Item
Comments on any particularities during blood sampling and testing. Please specify measuring point
text
C0947611 (UMLS CUI [1])
Sample of perfusate
Item
Sample of perfusate taken?
boolean
C0200345 (UMLS CUI [1,1])
C0029704 (UMLS CUI [1,2])
Item
Measuring point (from start of perfusion)
text
C0242485 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
Measuring point
Code List
Measuring point (from start of perfusion)
CL Item
0min (before application of chemo) (1)
CL Item
15min (2)
CL Item
30min (3)
CL Item
45min (4)
CL Item
60min (5)
CL Item
75min (6)
CL Item
90min (7)
Measuring point
Item
Measuring point valid?
boolean
C0242485 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
Concentration of Cisplatin
Item
Concentration of Cisplatin
text
C0365714 (UMLS CUI [1])
Comments
Item
Comments on any particularities during perfusate sampling and testing. Please specify measuring point
text
C0947611 (UMLS CUI [1])
CTCAE
Item
Recording of CTCAE: Have any AE occurred perioperative or since the last Visit? If "Yes" please fill in AE-Form
boolean
C1516728 (UMLS CUI [1])
Concomitant agent
Item
Has concomitant medication been subject to change? If "Yes" please fill in Concomitant medication form.
boolean
C2347852 (UMLS CUI [1])
Item Group
Confirmation of correctness
Confirmation
Item
Confirmatin of investigator: I hereby confirm that I personally checked this CRF for completeness and correctness. All data and statements in this CRF are ,according to best knowlwdge ,complete and correct.
boolean
C0750484 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature of investigator
text
C1519316 (UMLS CUI [1])
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
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