ID

30756

Beskrivning

Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT00792363

Länk

https://clinicaltrials.gov/show/NCT00792363

Nyckelord

Versioner (1)
  1. 2018-06-19 2018-06-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00792363

Engelsk

Eligibility Metastatic Colorectal Cancer NCT00792363

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically verified adenocarcinoma in colon or rectum with metastatic spread.
Beskrivning

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic

Datatyp

boolean

Alias
UMLS CUI [1]
C4324497
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
no mutations in the kras gene.
Beskrivning

KRAS Gene Mutation Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1517649
UMLS CUI [1,2]
C0332197
resistance to 5-fu, oxaliplatin and irinotecan.
Beskrivning

Fluorouracil Resistant | Oxaliplatin Resistant | Irinotecan Resistant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0016360
UMLS CUI [1,2]
C0332325
UMLS CUI [2,1]
C0069717
UMLS CUI [2,2]
C0332325
UMLS CUI [3,1]
C0123931
UMLS CUI [3,2]
C0332325
age ≥18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ps 0-2.
Beskrivning

Performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965
measurable disease according to recist criteria.
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
haematology: neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes
Beskrivning

Hematology | Neutrophil count | White Blood Cell Count procedure | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0200627
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0032181
≥100 and bilirubinaemia ≤3 x upper normal value. samples no more than 4 weeks old.
Beskrivning

Bilirubinemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0020433
fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
Beskrivning

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
Beskrivning

Availability of Blood specimen | Availability of Tissue specimen | Evaluation Biological Markers

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1292533
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C0005516
oral and written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
Beskrivning

Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
Beskrivning

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
verified or clinically suspected cns metastasis.
Beskrivning

CNS metastases | CNS metastases Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0750491
other experimental treatment.
Beskrivning

Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0949266
serious medical disease according to investigator's judgement.
Beskrivning

Disease Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
pregnant or breastfeeding women.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hypersensitivity to the active substance or to one or more of the auxiliary substances.
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Adjuvants Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0001552
UMLS CUI [2,3]
C1265611
patients with interstitial pneumonitis or pulmonary fibrosis.
Beskrivning

Pneumonia, Interstitial | Pulmonary Fibrosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C0034069
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00792363

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic
Item
histologically verified adenocarcinoma in colon or rectum with metastatic spread.
boolean
C4324497 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
KRAS Gene Mutation Absent
Item
no mutations in the kras gene.
boolean
C1517649 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Fluorouracil Resistant | Oxaliplatin Resistant | Irinotecan Resistant
Item
resistance to 5-fu, oxaliplatin and irinotecan.
boolean
C0016360 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0069717 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
C0123931 (UMLS CUI [3,1])
C0332325 (UMLS CUI [3,2])
Age
Item
age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Performance status
Item
ps 0-2.
boolean
C1518965 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to recist criteria.
boolean
C1513041 (UMLS CUI [1])
Hematology | Neutrophil count | White Blood Cell Count procedure | Platelet Count measurement
Item
haematology: neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes
boolean
C0200627 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Bilirubinemia
Item
≥100 and bilirubinaemia ≤3 x upper normal value. samples no more than 4 weeks old.
boolean
C0020433 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Availability of Blood specimen | Availability of Tissue specimen | Evaluation Biological Markers
Item
acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
boolean
C0470187 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C0005516 (UMLS CUI [3,2])
Informed Consent
Item
oral and written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
CNS metastases | CNS metastases Suspected
Item
verified or clinically suspected cns metastasis.
boolean
C0686377 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Therapy, Investigational
Item
other experimental treatment.
boolean
C0949266 (UMLS CUI [1])
Disease Serious
Item
serious medical disease according to investigator's judgement.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Adjuvants Quantity
Item
hypersensitivity to the active substance or to one or more of the auxiliary substances.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0001552 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Pneumonia, Interstitial | Pulmonary Fibrosis
Item
patients with interstitial pneumonitis or pulmonary fibrosis.
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])
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