ID

44312

Beskrivning

Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00713128

Länk

https://clinicaltrials.gov/show/NCT00713128

Nyckelord

Versioner (2)
  1. 2017-12-27 2017-12-27 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00713128

Engelsk

Eligibility Colorectal Cancer NCT00713128

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with colorectal cancer receiving irinotecan in combination with infusional fluorouracil and leucovorin (folfri) with or without bevacizumab or irinotecan in combination with cetuximab
Beskrivning

Colorectal Carcinoma | irinotecan | Fluorouracil Infusion | Combined Modality Therapy | Leucovorin | FOLFIRI | bevacizumab | cetuximab

Datatyp

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2]
C0123931
UMLS CUI [3,1]
C0016360
UMLS CUI [3,2]
C1827465
UMLS CUI [4]
C0009429
UMLS CUI [5]
C0023413
UMLS CUI [6]
C1880658
UMLS CUI [7]
C0796392
UMLS CUI [8]
C0995188
all patients will receive the following standard antiemetic regimen prior to chemotherapy:
Beskrivning

Antiemetics | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0003297
UMLS CUI [2]
C0392920
dexamethasone 8 mg po/iv
Beskrivning

Oral dexamethasone | Dexamethasone Intravenous

Datatyp

boolean

Alias
UMLS CUI [1]
C0360528
UMLS CUI [2,1]
C0011777
UMLS CUI [2,2]
C1522726
an approved dose of a 5ht3 receptor antagonist. ondansetron 8mg iv or 24mg po dolasetron 100mg iv/po granisetron 1 mg iv or 2mg po use of palonosetron will be excluded on this trial no routine prophylaxis for delayed emesis will be given. patients will be instructed in the use of rescue antiemetics if needed.
Beskrivning

5HT3 Receptor Antagonists | Ondansetron Intravenous Excluded | Oral dolasetron Excluded | Granisetron Intravenous Excluded | Oral granisetron Excluded | Palonosetron Intravenous Excluded | Palonosetron Oral Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C2917245
UMLS CUI [2,1]
C0061851
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C2828389
UMLS CUI [3,1]
C3214577
UMLS CUI [3,2]
C2828389
UMLS CUI [4,1]
C0061863
UMLS CUI [4,2]
C1522726
UMLS CUI [4,3]
C2828389
UMLS CUI [5,1]
C3211320
UMLS CUI [5,2]
C2828389
UMLS CUI [6,1]
C0220578
UMLS CUI [6,2]
C1522726
UMLS CUI [6,3]
C2828389
UMLS CUI [7,1]
C0220578
UMLS CUI [7,2]
C1527415
UMLS CUI [7,3]
C2828389
minimum age of 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
premenopausal patients must demonstrate a negative serum or urine pregnancy test prior to receiving chemotherapy.
Beskrivning

Premenopausal state Serum pregnancy test negative | Premenopausal state Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0430057
ecog performance status of 0-2 (appendix a)
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
execution of written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with history of moderate-severe nausea or any vomiting with prior chemotherapy including irinotecan based chemotherapy.
Beskrivning

Nausea Moderate | Nausea Severe | Vomiting | Prior Chemotherapy | Chemotherapy Irinotecan Based

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027497
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0027497
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0042963
UMLS CUI [4]
C1514457
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0123931
UMLS CUI [5,3]
C1705938
concomitant use of any drug with potential antiemetic efficacy (appendix b) 24 hours before chemotherapy and during the 120 hour study period. chronic use (more than 2 weeks) of benzodiazepines is allowed.
Beskrivning

Antiemetics | Benzodiazepines chronic allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0003297
UMLS CUI [2,1]
C0005064
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0683607
vomiting, retching or nausea (nci > 1) in the 24 hours preceding chemotherapy
Beskrivning

Vomiting CTCAE Grades | Retching CTCAE Grades | Nausea CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0232602
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C0027497
UMLS CUI [3,2]
C1516728
palliative surgery < 2 weeks from study entry
Beskrivning

Palliative Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0282282
concurrent radiotherapy
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
Tillbaka till toppen

Similar models

Eligibility Colorectal Cancer NCT00713128

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma | irinotecan | Fluorouracil Infusion | Combined Modality Therapy | Leucovorin | FOLFIRI | bevacizumab | cetuximab
Item
patients with colorectal cancer receiving irinotecan in combination with infusional fluorouracil and leucovorin (folfri) with or without bevacizumab or irinotecan in combination with cetuximab
boolean
C0009402 (UMLS CUI [1])
C0123931 (UMLS CUI [2])
C0016360 (UMLS CUI [3,1])
C1827465 (UMLS CUI [3,2])
C0009429 (UMLS CUI [4])
C0023413 (UMLS CUI [5])
C1880658 (UMLS CUI [6])
C0796392 (UMLS CUI [7])
C0995188 (UMLS CUI [8])
Antiemetics | Chemotherapy
Item
all patients will receive the following standard antiemetic regimen prior to chemotherapy:
boolean
C0003297 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Oral dexamethasone | Dexamethasone Intravenous
Item
dexamethasone 8 mg po/iv
boolean
C0360528 (UMLS CUI [1])
C0011777 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
5HT3 Receptor Antagonists | Ondansetron Intravenous Excluded | Oral dolasetron Excluded | Granisetron Intravenous Excluded | Oral granisetron Excluded | Palonosetron Intravenous Excluded | Palonosetron Oral Excluded
Item
an approved dose of a 5ht3 receptor antagonist. ondansetron 8mg iv or 24mg po dolasetron 100mg iv/po granisetron 1 mg iv or 2mg po use of palonosetron will be excluded on this trial no routine prophylaxis for delayed emesis will be given. patients will be instructed in the use of rescue antiemetics if needed.
boolean
C2917245 (UMLS CUI [1])
C0061851 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C3214577 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0061863 (UMLS CUI [4,1])
C1522726 (UMLS CUI [4,2])
C2828389 (UMLS CUI [4,3])
C3211320 (UMLS CUI [5,1])
C2828389 (UMLS CUI [5,2])
C0220578 (UMLS CUI [6,1])
C1522726 (UMLS CUI [6,2])
C2828389 (UMLS CUI [6,3])
C0220578 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C2828389 (UMLS CUI [7,3])
Age
Item
minimum age of 18 years.
boolean
C0001779 (UMLS CUI [1])
Premenopausal state Serum pregnancy test negative | Premenopausal state Urine pregnancy test negative
Item
premenopausal patients must demonstrate a negative serum or urine pregnancy test prior to receiving chemotherapy.
boolean
C0232969 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0-2 (appendix a)
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
execution of written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Nausea Moderate | Nausea Severe | Vomiting | Prior Chemotherapy | Chemotherapy Irinotecan Based
Item
patients with history of moderate-severe nausea or any vomiting with prior chemotherapy including irinotecan based chemotherapy.
boolean
C0027497 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0042963 (UMLS CUI [3])
C1514457 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C0123931 (UMLS CUI [5,2])
C1705938 (UMLS CUI [5,3])
Antiemetics | Benzodiazepines chronic allowed
Item
concomitant use of any drug with potential antiemetic efficacy (appendix b) 24 hours before chemotherapy and during the 120 hour study period. chronic use (more than 2 weeks) of benzodiazepines is allowed.
boolean
C0003297 (UMLS CUI [1])
C0005064 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Vomiting CTCAE Grades | Retching CTCAE Grades | Nausea CTCAE Grades
Item
vomiting, retching or nausea (nci > 1) in the 24 hours preceding chemotherapy
boolean
C0042963 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0232602 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0027497 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Palliative Surgery
Item
palliative surgery < 2 weeks from study entry
boolean
C0282282 (UMLS CUI [1])
Therapeutic radiology procedure
Item
concurrent radiotherapy
boolean
C1522449 (UMLS CUI [1])
Tillbaka till toppen 

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