ID

37421

Beschrijving

Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02305758

Link

https://clinicaltrials.gov/show/NCT02305758

Trefwoorden

  1. 24-07-19 24-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 juli 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Untreated Metastatic Colorectal Cancer NCT02305758

Eligibility Untreated Metastatic Colorectal Cancer NCT02305758

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
Beschrijving

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic

Datatype

boolean

Alias
UMLS CUI [1]
C4324497
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
at least 1 unresectable lesion on a ct (computerized tomography) scan that is measurable as defined by recist, version 1.1
Beschrijving

Lesion unresectable Quantity | Measurable lesion CT scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0040405
ecog (eastern cooperative oncology group) performance score of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic, renal and hepatic function
Beschrijving

Hematologic function | Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior anti-cancer treatment for metastatic colorectal cancer
Beschrijving

Cancer treatment Colorectal cancer metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0948380
prior exposure to parp (poly adp-ribose polymerase) inhibitors
Beschrijving

Exposure to Poly(ADP-ribose) Polymerase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1882413
the last course of adjuvant chemotherapy must have ended > 12 months prior to colorectal cancer recurrence
Beschrijving

Adjuvant Chemotherapy Completed | Status pre- Colorectal cancer recurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0854750
any clinically significant and uncontrolled major medical condition
Beschrijving

Medical condition Major Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0205318
participant is pregnant or lactating
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any medical condition, which in the opinion of the study investigator, places the participant at an unacceptably high risk for toxicities
Beschrijving

Medical condition High risk of Toxicities

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0600688
for those receiving bevacizumab, standard medical exclusionary conditions apply
Beschrijving

bevacizumab

Datatype

boolean

Alias
UMLS CUI [1]
C0796392

Similar models

Eligibility Untreated Metastatic Colorectal Cancer NCT02305758

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic
Item
histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
boolean
C4324497 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Lesion unresectable Quantity | Measurable lesion CT scan
Item
at least 1 unresectable lesion on a ct (computerized tomography) scan that is measurable as defined by recist, version 1.1
boolean
C0221198 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
ECOG performance status
Item
ecog (eastern cooperative oncology group) performance score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Colorectal cancer metastatic
Item
prior anti-cancer treatment for metastatic colorectal cancer
boolean
C0920425 (UMLS CUI [1,1])
C0948380 (UMLS CUI [1,2])
Exposure to Poly(ADP-ribose) Polymerase Inhibitors
Item
prior exposure to parp (poly adp-ribose polymerase) inhibitors
boolean
C0332157 (UMLS CUI [1,1])
C1882413 (UMLS CUI [1,2])
Adjuvant Chemotherapy Completed | Status pre- Colorectal cancer recurrent
Item
the last course of adjuvant chemotherapy must have ended > 12 months prior to colorectal cancer recurrence
boolean
C0085533 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0854750 (UMLS CUI [2,2])
Medical condition Major Uncontrolled
Item
any clinically significant and uncontrolled major medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
participant is pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition High risk of Toxicities
Item
any medical condition, which in the opinion of the study investigator, places the participant at an unacceptably high risk for toxicities
boolean
C3843040 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
bevacizumab
Item
for those receiving bevacizumab, standard medical exclusionary conditions apply
boolean
C0796392 (UMLS CUI [1])

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