ID

12192

Description

Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Thereapy for the Treatment of Unrespectable Recurrent Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT02438995

Link

https://clinicaltrials.gov/show/NCT02438995

Keywords

Versions (1)
  1. 10/12/15 10/12/15 -
Uploaded on

October 12, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Squamous Cell NCT02438995

English

Eligibility Carcinoma, Squamous Cell NCT02438995

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients of 18 years of age.
Description

gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
2. patients with a documented diagnosis of recurrent head and neck squamous cell carcinoma patients must have at least one confirmed and evaluable tumor site.* the recurrence must have bidimensional measurements by clinical examination or ct scan. a confirmed recurrence site may also be biopsy-proven
Description

diagnosis; head and neck squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C1168401
3. tumor recurrence which is surgically unresectable (appendix)
Description

recurrent tumor unresectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0521158
UMLS CUI [1,2]
C1519810
4. patients must have a karnofsky performance status ≥70% (or the equivalent ecog level of 0-2) (see appendix performance status evaluation) and an expected survival of ≥ three months.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
5. patients must have adequate hematologic reserve with wbc≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. patients who are on coumadin must have a platelet count of ≥150,000/ mm3
Description

hematologic; reserve cell adequate

Data type

boolean

Alias
UMLS CUI [1]
C0205488
UMLS CUI [2,1]
C1514890
UMLS CUI [2,2]
C0205411
6. pre-enrollment chemistry parameters must show: bilirubin<1.5x the institutional upper limit of normal (iunl); ast or alt<2.5x iunl and creatinine<1.5x iunl.
Description

Blood Chemical Analysis

Data type

boolean

Alias
UMLS CUI [1]
C0005774
7. pre-enrollment coagulation parameters (pt and ptt) must be ≤1.5x the iunl.
Description

Blood coagulation tests

Data type

boolean

Alias
UMLS CUI [1]
C0005790
8. patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. a pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
9. patients must be able to understand and give written informed consent. informed consent must be obtained at the time of patient screening.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
10. patients who refuse surgery.
Description

Refused Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0749192
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who are pregnant or lactating.
Description

pregnant; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
2. women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
Description

Fertility

Data type

boolean

Alias
UMLS CUI [1]
C0015895
3. patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
Description

Intercurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0277557
4. pre-existing cardiac or respiratory disorders
Description

Heart Diseases; respiratory disorders

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0035204
5. unrelated malignancy within 3 years
Description

malignancy unrelated

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0445356
6. history of hypersensitivity reactions to other egfr inhibitors
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0020517
7. metastatic disease
Description

metastatic; disease

Data type

boolean

Alias
UMLS CUI [1]
C0036525
UMLS CUI [2]
C0012634
8. less than 6 months from prior radiation therapy (arm 1)
Description

radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
9. previous exposure to cetuximab
Description

cetuximab; exposure

Data type

boolean

Alias
UMLS CUI [1]
C0995188
UMLS CUI [2]
C0332157
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Similar models

Eligibility Carcinoma, Squamous Cell NCT02438995

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
gender
Item
1. male or female patients of 18 years of age.
boolean
C0079399 (UMLS CUI [1])
diagnosis; head and neck squamous cell carcinoma
Item
2. patients with a documented diagnosis of recurrent head and neck squamous cell carcinoma patients must have at least one confirmed and evaluable tumor site.* the recurrence must have bidimensional measurements by clinical examination or ct scan. a confirmed recurrence site may also be biopsy-proven
boolean
C0011900 (UMLS CUI [1])
C1168401 (UMLS CUI [2])
recurrent tumor unresectable
Item
3. tumor recurrence which is surgically unresectable (appendix)
boolean
C0521158 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
4. patients must have a karnofsky performance status ≥70% (or the equivalent ecog level of 0-2) (see appendix performance status evaluation) and an expected survival of ≥ three months.
boolean
C0206065 (UMLS CUI [1])
hematologic; reserve cell adequate
Item
5. patients must have adequate hematologic reserve with wbc≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. patients who are on coumadin must have a platelet count of ≥150,000/ mm3
boolean
C0205488 (UMLS CUI [1])
C1514890 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
Blood Chemical Analysis
Item
6. pre-enrollment chemistry parameters must show: bilirubin<1.5x the institutional upper limit of normal (iunl); ast or alt<2.5x iunl and creatinine<1.5x iunl.
boolean
C0005774 (UMLS CUI [1])
Blood coagulation tests
Item
7. pre-enrollment coagulation parameters (pt and ptt) must be ≤1.5x the iunl.
boolean
C0005790 (UMLS CUI [1])
contraception
Item
8. patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. a pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
9. patients must be able to understand and give written informed consent. informed consent must be obtained at the time of patient screening.
boolean
C0021430 (UMLS CUI [1])
Refused Surgery
Item
10. patients who refuse surgery.
boolean
C0749192 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant; lactating
Item
1. women who are pregnant or lactating.
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
Fertility
Item
2. women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
boolean
C0015895 (UMLS CUI [1])
Intercurrent disease
Item
3. patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
boolean
C0277557 (UMLS CUI [1])
Heart Diseases; respiratory disorders
Item
4. pre-existing cardiac or respiratory disorders
boolean
C0018799 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
malignancy unrelated
Item
5. unrelated malignancy within 3 years
boolean
C0006826 (UMLS CUI [1,1])
C0445356 (UMLS CUI [1,2])
hypersensitivity
Item
6. history of hypersensitivity reactions to other egfr inhibitors
boolean
C0020517 (UMLS CUI [1])
metastatic; disease
Item
7. metastatic disease
boolean
C0036525 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
radiation therapy
Item
8. less than 6 months from prior radiation therapy (arm 1)
boolean
C1522449 (UMLS CUI [1])
cetuximab; exposure
Item
9. previous exposure to cetuximab
boolean
C0995188 (UMLS CUI [1])
C0332157 (UMLS CUI [2])
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