ID

23172

Description

Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar; ODM derived from: https://clinicaltrials.gov/show/NCT00476476

Link

https://clinicaltrials.gov/show/NCT00476476

Keywords

Versions (1)
  1. 6/26/17 6/26/17 -
Uploaded on

June 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma NCT00476476

English

Eligibility Squamous Cell Carcinoma NCT00476476

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed measurable squamous cell carcinoma of the vulvar with an assessable lesion on the vulva or measurable metastatic disease. tumors may be primary or recurrent. patients must have plans for surgery or definitive treatment with chemotherapy +/-radiation unless they have measurable metastatic disease.
Description

Squamous cell carcinoma of vulva Measurable | Lesion of vulva Assessment | Neoplasm Metastasis Measurable | Primary tumor | Recurrent tumor | Operative Surgical Procedures Planned | Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0280856
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C0221784
UMLS CUI [2,2]
C1516048
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1513040
UMLS CUI [4]
C0677930
UMLS CUI [5]
C0521158
UMLS CUI [6,1]
C0543467
UMLS CUI [6,2]
C1301732
UMLS CUI [7]
C0392920
UMLS CUI [8]
C1522449
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
no concurrent chemotherapy or radiotherapy
Description

Chemotherapy Absent | Therapeutic radiology procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
no previous chemotherapy or radiotherapy within the preceding 1 month
Description

Prior Chemotherapy Absent | Prior radiation therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
ecog performance status of 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity reaction to erlotinib
Description

Hypersensitivity erlotinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
other coexisting malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma
Description

Malignant Neoplasms | Basal cell carcinoma Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C2828389
treatment with a non-fda approved or investigational drug within 30 days
Description

Drugs, Non-Prescription | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0013230
persistent toxicities (grade 2 or above) from previous treatment, expect alopecia or lymphedema
Description

Prior Therapy | Toxicity persistent CTCAE Grades | Alopecia | Lymphedema

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0205322
UMLS CUI [2,3]
C1516728
UMLS CUI [3]
C0002170
UMLS CUI [4]
C0024236
serum creatinine level greater than ctc grade 2
Description

Creatinine measurement, serum | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1516728
pregnancy or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe or uncontrolled systemic disease
Description

Systemic disease Severe | Systemic disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
Description

Disease Study Subject Participation Status At risk | Laboratory test finding Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
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Similar models

Eligibility Squamous Cell Carcinoma NCT00476476

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of vulva Measurable | Lesion of vulva Assessment | Neoplasm Metastasis Measurable | Primary tumor | Recurrent tumor | Operative Surgical Procedures Planned | Chemotherapy | Therapeutic radiology procedure
Item
histologically confirmed measurable squamous cell carcinoma of the vulvar with an assessable lesion on the vulva or measurable metastatic disease. tumors may be primary or recurrent. patients must have plans for surgery or definitive treatment with chemotherapy +/-radiation unless they have measurable metastatic disease.
boolean
C0280856 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0221784 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0677930 (UMLS CUI [4])
C0521158 (UMLS CUI [5])
C0543467 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
C0392920 (UMLS CUI [7])
C1522449 (UMLS CUI [8])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
no concurrent chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Prior Chemotherapy Absent | Prior radiation therapy Absent
Item
no previous chemotherapy or radiotherapy within the preceding 1 month
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity erlotinib
Item
known hypersensitivity reaction to erlotinib
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
Malignant Neoplasms | Basal cell carcinoma Excluded
Item
other coexisting malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Drugs, Non-Prescription | Investigational New Drugs
Item
treatment with a non-fda approved or investigational drug within 30 days
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Prior Therapy | Toxicity persistent CTCAE Grades | Alopecia | Lymphedema
Item
persistent toxicities (grade 2 or above) from previous treatment, expect alopecia or lymphedema
boolean
C1514463 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C0002170 (UMLS CUI [3])
C0024236 (UMLS CUI [4])
Creatinine measurement, serum | CTCAE Grades
Item
serum creatinine level greater than ctc grade 2
boolean
C0201976 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease Severe | Systemic disease Uncontrolled
Item
severe or uncontrolled systemic disease
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Disease Study Subject Participation Status At risk | Laboratory test finding Study Subject Participation Status At risk
Item
significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
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