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ID
13572
Beschrijving
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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- 17-02-16 17-02-16 -
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17 februari 2016
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Visit 13 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv
Case Report Form (HIPEC) Visit 13
- StudyEvent: ODM
Similar models
Case Report Form (HIPEC) Visit 13
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Visit 13: Fifth cycle of post-OP Chemotherapy
Patient ID
Item
Patient ID
integer
C1269815 (UMLS CUI [1])
CRF number
Item
CRF number
integer
C1516308 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Patient Visit
Item
Has patient appeared for the planned visit?
boolean
C1512346 (UMLS CUI [1])
Patient visit
Item
If patient didn´t come for the scheduled visit, please call the patient and try to verify the reason why.
text
C1512346 (UMLS CUI [1])
Patient deceased
Item
Is the Patient deceased?
boolean
C1555024 (UMLS CUI [1])
Date of death
Item
Please specify the date the patient died
date
C0011008 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
C0011065 (UMLS CUI [1,2])
Progressive disease
Item
Has a progressive disease been diagnosed?
boolean
C1335499 (UMLS CUI [1])
Progressive Disease date
Item
Please give the date, the progression was diagnosed
date
C1335499 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Relapse
Item
Recurrent Disease
boolean
C0277556 (UMLS CUI [1])
Date of relapse
Item
Please give the date, the relapse was diagnosed
boolean
C0035020 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CTCAE
Item
Recording of CTCAE: Have any AE occurred since the last Visit? If `Yes` please fill in AE-Form
boolean
C1516728 (UMLS CUI [1])
Postoperative chemotherapy
Item
Postoperative chemotherapy will be continued
boolean
C0032790 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
Postoperative chemotherapy
Item
Please specify the reason why, if chemotherapy will be discontinued
text
C0032790 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
Item
If chemotherapy will be continued, please specify the nature of the regimen used
text
C0032790 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
Code List
If chemotherapy will be continued, please specify the nature of the regimen used
CL Item
monotherapy (1)
CL Item
combination therapy (2)
Item
Please specify the agent used for chemotherapy
text
C0032790 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
CL Item
Carboplatin (1)
CL Item
Paclitaxel (2)
CL Item
Gemcitabine (used on first or eighth day of cycle) (3)
CL Item
Doxorubicin liposome (4)
CL Item
other (5)
Other antineoplastic agent
Item
Please specify other chemotherapeutic agent used
text
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Carboplatin
Item
Dose of Carboplatin administered
float
C0079083 (UMLS CUI [1])
Paclitaxel
Item
Dose of Paclitaxel administered
float
C0144576 (UMLS CUI [1])
Gemcitabine
Item
Dose of Gemcitabine administered
float
C0045093 (UMLS CUI [1])
Doxorubicin liposome
Item
Dose of Doxorubicin liposome administered
float
C0717726 (UMLS CUI [1])
Other antineoplastic agent
Item
Dose of other antineoplastic agent administered
float
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Date of third chemotherapy
Item
Date of third chemotherapy cycle
date
C0011008 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
Total dose of antineoplastic agent
Item
Total dose of Carboplatin administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification was used
text
C1707811 (UMLS CUI [1])
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
CL Item
hematologic toxicity (1)
CL Item
hypersensitivity (2)
CL Item
other (3)
Total dose of antineoplastic agent
Item
Total dose of Paclitaxel administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification was used
text
C1707811 (UMLS CUI [1])
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
CL Item
hematologic toxicity (1)
CL Item
hypersensitivity (2)
CL Item
other (3)
Total dose of antineoplastic agent
Item
Total dose of Gemcitabine administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification was used
text
C1707811 (UMLS CUI [1])
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
CL Item
hematologic toxicity (1)
CL Item
hypersensitivity (2)
CL Item
other (3)
Total dose of antineoplastic agent
Item
Total dose of doxorubicin liposome administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification has been used
text
C1707811 (UMLS CUI [1])
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
CL Item
hematologic toxicity (1)
CL Item
hypersensitivity (2)
CL Item
other (3)
Total dose of antineoplastic agent
Item
Total dose of other chemotherapeutic agent administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification has been used
text
C1707811 (UMLS CUI [1])
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
CL Item
hematologic toxicity (1)
CL Item
hypersensitivity (2)
CL Item
other (3)
Further antineoplastic treatment
Item
Any further oncologic treatments?
boolean
C0920425 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,2])
Further antineoplastic treatment
Item
Please specify any further antineoplastic treatments that have been carried out.
text
C0920425 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,2])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
Signature
Item
Signature by investigator: I personally controlled all entries into this form for this patient. All data and statements in this CRF are complete and correct
text
C1519316 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])