ID

27577

Description

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Progress Hinweis: Bis Visit 10 (nach letztem Zyklus der Chemotherapie) bedeutet die Feststellung eines Progresses: Abbruch der Studientherapie: AS – Bogen ausfüllen Bei klinischem Tumorprogress (vor der OP - bis Woche 12) ist für diesen Patienten der Abbruch der Studientherapie zu beschließen. Patienten, die im Behandlungsarm B therapiert werden, soll die HIPEC ohne zytoreduktive Chirurgie (nach Ausschluss von Kontraindikationen) durchgeführt werden. Die Weiterbehandlung erfolgt nach Ermessen des behandelnden Arztes.

Keywords

Versions (1)
  1. 11/20/17 11/20/17 -
Copyright Holder

Beate Rau

Uploaded on

November 20, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC)

German

Progress

1 forms  
  1. StudyEvent: ODM
    1. Progress
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Zentrum-ID
Description

Center Identification

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patienten-ID
Description

Patient Identification

Data type

integer

Alias
UMLS CUI [1]
C2348585
Geburtsjahr
Description

Year of birth

Data type

partialDate

Alias
UMLS CUI [1]
C2826771
Follow up Nr.: (ergänzen Sie hier die fortlaufende Nummer: 02, 03, 04 usw.)
Description

Number of Follow up

Data type

integer

Alias
UMLS CUI [1,1]
C1704685
UMLS CUI [1,2]
C0237753
Progress
Description

Progress

Alias
UMLS CUI-1
C0242656
UMLS CUI-2
C0006826
Progress festgestellt am (keine SAE-Meldung)
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0242656
UMLS CUI [1,3]
C1511790
Progress nachgewiesen mit
Description

Diagnostic procedure

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0242656
Lokalisation des Progresses
Description

Localization

Data type

text

Alias
UMLS CUI [1,1]
C0475264
UMLS CUI [1,2]
C0242656
Metastasen
Description

Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
Metastasen, wenn ja
Description

Localization of metastases

Data type

text

Alias
UMLS CUI [1,1]
C0475264
UMLS CUI [1,2]
C0027627
Andere Metastasen
Description

Other metastases

Data type

text

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205394
Therapie des Progresses
Description

Progress therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0242656
Therapie des Progresses
Description

Progress therapy

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0242656
andere Therapie des Progresses
Description

Other progress therapy

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0242656
UMLS CUI [1,3]
C0205394
Administrative Dokumentation
Description

Administrative Dokumentation

Alias
UMLS CUI-1
C1320722
CRF-Inhalt bestätigt am:
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Name (Druckbuchstaben)
Description

Name

Data type

text

Alias
UMLS CUI [1]
C0027365
Unterschrift
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Progress

1 forms
  1. StudyEvent: ODM
    1. Progress
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Center Identification
Item
Zentrum-ID
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Identification
Item
Patienten-ID
integer
C2348585 (UMLS CUI [1])
Year of birth
Item
Geburtsjahr
partialDate
C2826771 (UMLS CUI [1])
Number of Follow up
Item
Follow up Nr.: (ergänzen Sie hier die fortlaufende Nummer: 02, 03, 04 usw.)
integer
C1704685 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Progress
C0242656 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
Date
Item
Progress festgestellt am (keine SAE-Meldung)
date
C0011008 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C1511790 (UMLS CUI [1,3])
Item
Progress nachgewiesen mit
text
C0430022 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Diagnostic procedure
Code List
Progress nachgewiesen mit
CL Item
Histologie (Histologie)
CL Item
Laparoskopie (Laparoskopie)
CL Item
Laparotomie (Laparotomie)
CL Item
Progredienter Aszites mit positiver Zytologie (Progredienter Aszites mit positiver Zytologie)
CL Item
MRT (MRT)
CL Item
PET (PET)
CL Item
CT (CT)
CL Item
Sonographie (Sonographie)
CL Item
Tumormarker CEA und/oder CA 72-4 (Tumormarker CEA und/oder CA 72-4)
CL Item
klinische Symptome (klinische Symptome)
Item
Lokalisation des Progresses
text
C0475264 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Localization
Code List
Lokalisation des Progresses
CL Item
abdominal (abdominal)
CL Item
extraabdominal (extraabdominal)
Metastasis
Item
Metastasen
boolean
C0027627 (UMLS CUI [1])
Item
Metastasen, wenn ja
text
C0475264 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Localization of metastases
Code List
Metastasen, wenn ja
CL Item
Peritoneum (Peritoneum)
CL Item
Leber (Leber)
CL Item
Lunge (Lunge)
CL Item
Knochen (Knochen)
CL Item
ZNS (ZNS)
CL Item
Andere (Andere)
Other metastases
Item
Andere Metastasen
text
C0027627 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Progress therapy
Item
Therapie des Progresses
boolean
C0087111 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Item
Therapie des Progresses
text
C0087111 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Progress therapy
Code List
Therapie des Progresses
CL Item
Operation (SInt-Bogen ausfüllen) (Operation (SInt-Bogen ausfüllen))
CL Item
Chemotherapie (Chemotherapie)
CL Item
Radiotherapie (Radiotherapie)
CL Item
palliative Therapie (palliative Therapie)
CL Item
Andere (Andere)
Other progress therapy
Item
andere Therapie des Progresses
text
C0087111 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Administrative Dokumentation
C1320722 (UMLS CUI-1)
Date
Item
CRF-Inhalt bestätigt am:
date
C0011008 (UMLS CUI [1])
Name
Item
Name (Druckbuchstaben)
text
C0027365 (UMLS CUI [1])
Signature
Item
Unterschrift
text
C1519316 (UMLS CUI [1])
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