ID

37001

Beskrivning

Study for Treatment of Patients With Recurrent or Metastatic SCCHN or SCCS; ODM derived from: https://clinicaltrials.gov/show/NCT02449681

Länk

https://clinicaltrials.gov/show/NCT02449681

Nyckelord

Versioner (1)
  1. 2019-06-27 2019-06-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin NCT02449681

Engelsk

Eligibility Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin NCT02449681

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
eastern cooperative oncology group (ecog) performance status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
confirmed squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin
Beskrivning

Squamous cell carcinoma of the head and neck | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of mouth | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1]
C1168401
UMLS CUI [2]
C0280313
UMLS CUI [3]
C0585362
UMLS CUI [4]
C0280321
UMLS CUI [5]
C0280324
UMLS CUI [6]
C0553723
for patients with oropharyngeal cancer, p16 status is known or can be determined
Beskrivning

Oropharyngeal Carcinoma | P16 Status Known

Datatyp

boolean

Alias
UMLS CUI [1]
C2349952
UMLS CUI [2,1]
C2354136
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0205309
measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
acceptable laboratory results as indicated by protocol
Beskrivning

Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
acceptable cardiac function as indicated by protocol
Beskrivning

Cardiac function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232164
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
received prior egfr tki therapy for recurrent or metastatic scc (e.g., oral egfr tkis such as erlotinib, gefitinib, or afatinib)•family history of long qtc syndrome
Beskrivning

Epidermal growth factor receptor inhibitor Recurrent squamous cell carcinoma | Epidermal growth factor receptor inhibitor Metastatic squamous cell carcinoma | Epidermal growth factor receptor inhibitor Oral | erlotinib | gefitinib | Afatinib | Family history of long QT syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1443775
UMLS CUI [1,2]
C4304995
UMLS CUI [2,1]
C1443775
UMLS CUI [2,2]
C0334246
UMLS CUI [3,1]
C1443775
UMLS CUI [3,2]
C1527415
UMLS CUI [4]
C1135135
UMLS CUI [5]
C1122962
UMLS CUI [6]
C2987648
UMLS CUI [7]
C3839836
receiving medication that prolongs qt interval ,with a risk of causing torsades de pointes (tdp), unless ecg meets inclusion criteria while on a stable dose of the medication
Beskrivning

Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations At risk Torsades de Pointes | Exception ECG Fulfill Inclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0040479
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0013798
UMLS CUI [3,3]
C1550543
UMLS CUI [3,4]
C1512693
family history of long qtc syndrome
Beskrivning

Family history of long QT syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C3839836
symptomatic central nervous system (cns) lesions, or cns lesions that require therapy
Beskrivning

Central nervous system lesion Symptomatic | Central nervous system lesion Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0742468
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0742468
UMLS CUI [2,2]
C0332121
radiation therapy within 2 weeks prior to the first dose of study medication
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
Beskrivning

Major surgery | Minor Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0038904
concurrent active malignancy requiring systemic treatment
Beskrivning

Malignant Neoplasms Requirement Systemic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
Beskrivning

Disease Serious Interferes with Completion of clinical trial | Mental condition Interferes with Completion of clinical trial | Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2732579
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3]
C0009450
pregnant or breast-feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin NCT02449681

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of mouth | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Squamous cell carcinoma of skin
Item
confirmed squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin
boolean
C1168401 (UMLS CUI [1])
C0280313 (UMLS CUI [2])
C0585362 (UMLS CUI [3])
C0280321 (UMLS CUI [4])
C0280324 (UMLS CUI [5])
C0553723 (UMLS CUI [6])
Oropharyngeal Carcinoma | P16 Status Known
Item
for patients with oropharyngeal cancer, p16 status is known or can be determined
boolean
C2349952 (UMLS CUI [1])
C2354136 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
Measurable Disease
Item
measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
boolean
C1513041 (UMLS CUI [1])
Laboratory Results
Item
acceptable laboratory results as indicated by protocol
boolean
C1254595 (UMLS CUI [1])
Cardiac function
Item
acceptable cardiac function as indicated by protocol
boolean
C0232164 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Epidermal growth factor receptor inhibitor Recurrent squamous cell carcinoma | Epidermal growth factor receptor inhibitor Metastatic squamous cell carcinoma | Epidermal growth factor receptor inhibitor Oral | erlotinib | gefitinib | Afatinib | Family history of long QT syndrome
Item
received prior egfr tki therapy for recurrent or metastatic scc (e.g., oral egfr tkis such as erlotinib, gefitinib, or afatinib)•family history of long qtc syndrome
boolean
C1443775 (UMLS CUI [1,1])
C4304995 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2,1])
C0334246 (UMLS CUI [2,2])
C1443775 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1135135 (UMLS CUI [4])
C1122962 (UMLS CUI [5])
C2987648 (UMLS CUI [6])
C3839836 (UMLS CUI [7])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations At risk Torsades de Pointes | Exception ECG Fulfill Inclusion criteria
Item
receiving medication that prolongs qt interval ,with a risk of causing torsades de pointes (tdp), unless ecg meets inclusion criteria while on a stable dose of the medication
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0040479 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0013798 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
C1512693 (UMLS CUI [3,4])
Family history of long QT syndrome
Item
family history of long qtc syndrome
boolean
C3839836 (UMLS CUI [1])
Central nervous system lesion Symptomatic | Central nervous system lesion Treatment required for
Item
symptomatic central nervous system (cns) lesions, or cns lesions that require therapy
boolean
C0742468 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0742468 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Therapeutic radiology procedure
Item
radiation therapy within 2 weeks prior to the first dose of study medication
boolean
C1522449 (UMLS CUI [1])
Major surgery | Minor Surgical Procedures
Item
major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
boolean
C0679637 (UMLS CUI [1])
C0038904 (UMLS CUI [2])
Malignant Neoplasms Requirement Systemic therapy
Item
concurrent active malignancy requiring systemic treatment
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Disease Serious Interferes with Completion of clinical trial | Mental condition Interferes with Completion of clinical trial | Communicable Disease
Item
any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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