ID

37264

Description

Pegylated Interferon Alpha-2b and Capecitabine in Unresectable/Metastatic Cutaneous Squamous Cell; ODM derived from: https://clinicaltrials.gov/show/NCT02218164

Link

https://clinicaltrials.gov/show/NCT02218164

Keywords

Versions (2)
  1. 7/12/19 7/12/19 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma of Skin NCT02218164

English

Eligibility Squamous Cell Carcinoma of Skin NCT02218164

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have histologically or cytologically confirmed squamous cell carcinoma of the skin. potential participants who present with "squamous cell carcinoma of unknown primary lesions" at the time of diagnosis will be eligible if patients have a plausible primary skin site removed in the past. similarly, potential participants with neck, parotid, or facial lymph nodes positive for squamous cell carcinoma with no identifiable mucosal primary would also be eligible.
Description

Squamous cell carcinoma of skin | Squamous cell carcinoma of unknown primary origin | Squamous cell carcinoma of skin of neck | Parotid Gland Squamous Cell Carcinoma | Squamous cell carcinoma Facial lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C0553723
UMLS CUI [2]
C0280097
UMLS CUI [3]
C1827711
UMLS CUI [4]
C1335367
UMLS CUI [5,1]
C0007137
UMLS CUI [5,2]
C0229719
must have measurable disease, defined by response according to response evaluation criteria in solid tumors (recist) v1.1 as at least one lesion that can be accurately measured in at least one dimension of >10 mm by ct, mri, or calipers
Description

Measurable Disease Quantity | Measurable lesion Dimension Quantity CT | Measurable lesion Dimension Quantity MRI | Measurable lesion Dimension Quantity Caliper

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0040405
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0439534
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0024485
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0439534
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0175720
there is no limitation to prior treatments with local, regional, topical or systemic agents, except for prior systemic treatment with 5-fluorouracil or prodrugs thereof. prior topical treatment with 5-fluorouracil is permitted. patients who are on chronic daily doses of prednisone of greater than 5 mg are excluded. there is no restriction on timing of last treatments as long as patients have recovered from all expected toxicities and at least 4 weeks have passed since last administration.
Description

Pharmaceutical Preparations Local | Pharmaceutical Preparations Regional | Pharmaceutical Preparations Topical | Pharmaceutical Preparations Systemic | Exception Systemic therapy Fluorouracil | Fluorouracil Topical Product allowed | Exclusion Prednisone chronic U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205147
UMLS CUI [2,3]
|C0013227
UMLS CUI [2,4]
C1710439
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1515119
UMLS CUI [4,3]
C0016360
UMLS CUI [5,1]
C3215191
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C2828389
UMLS CUI [6,2]
C0032952
UMLS CUI [6,3]
C0205191
UMLS CUI [6,4]
C0456683
life expectancy of greater than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group (ecog) performance status <=2 (karnofsky >=60%
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
must have normal organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
must not be candidates for curative locoregional treatments. patients with recurrent locoregional disease following surgery and/or radiation for who a resection is unacceptably morbid and unlikely to be curative are eligible.
Description

Patients Inappropriate Curative treatment Locoregional | Recurrent disease Locoregional | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure | Excision Unacceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1273390
UMLS CUI [1,4]
C1947913
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1947913
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1522449
UMLS CUI [5,1]
C0728940
UMLS CUI [5,2]
C1883420
women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Contraception, Barrier | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0004764
UMLS CUI [4]
C0036899
ability to understand and the willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Description

Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin | Adverse drug events Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5,1]
C0041755
UMLS CUI [5,2]
C2004454
UMLS CUI [5,3]
C0332268
may not be receiving any other investigational agents
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
known brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
history of allergic reactions attributed to compounds of similar chemical or biologic composition to either capecitabine or interferon
Description

Allergic Reaction Compound Similar Capecitabine | Allergic Reaction Compound Similar Interferon

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C2348205
UMLS CUI [1,4]
C0671970
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C2348205
UMLS CUI [2,4]
C3652465
uncontrolled, ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements
Description

Illness Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0439801
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
women who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Eligibility Squamous Cell Carcinoma of Skin NCT02218164

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of skin | Squamous cell carcinoma of unknown primary origin | Squamous cell carcinoma of skin of neck | Parotid Gland Squamous Cell Carcinoma | Squamous cell carcinoma Facial lymph nodes
Item
must have histologically or cytologically confirmed squamous cell carcinoma of the skin. potential participants who present with "squamous cell carcinoma of unknown primary lesions" at the time of diagnosis will be eligible if patients have a plausible primary skin site removed in the past. similarly, potential participants with neck, parotid, or facial lymph nodes positive for squamous cell carcinoma with no identifiable mucosal primary would also be eligible.
boolean
C0553723 (UMLS CUI [1])
C0280097 (UMLS CUI [2])
C1827711 (UMLS CUI [3])
C1335367 (UMLS CUI [4])
C0007137 (UMLS CUI [5,1])
C0229719 (UMLS CUI [5,2])
Measurable Disease Quantity | Measurable lesion Dimension Quantity CT | Measurable lesion Dimension Quantity MRI | Measurable lesion Dimension Quantity Caliper
Item
must have measurable disease, defined by response according to response evaluation criteria in solid tumors (recist) v1.1 as at least one lesion that can be accurately measured in at least one dimension of >10 mm by ct, mri, or calipers
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
C1513041 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
C1513041 (UMLS CUI [4,1])
C0439534 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0175720 (UMLS CUI [4,4])
Pharmaceutical Preparations Local | Pharmaceutical Preparations Regional | Pharmaceutical Preparations Topical | Pharmaceutical Preparations Systemic | Exception Systemic therapy Fluorouracil | Fluorouracil Topical Product allowed | Exclusion Prednisone chronic U/day
Item
there is no limitation to prior treatments with local, regional, topical or systemic agents, except for prior systemic treatment with 5-fluorouracil or prodrugs thereof. prior topical treatment with 5-fluorouracil is permitted. patients who are on chronic daily doses of prednisone of greater than 5 mg are excluded. there is no restriction on timing of last treatments as long as patients have recovered from all expected toxicities and at least 4 weeks have passed since last administration.
boolean
C0013227 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
|C0013227 (UMLS CUI [2,3])
C1710439 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
C0016360 (UMLS CUI [4,3])
C3215191 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C2828389 (UMLS CUI [6,1])
C0032952 (UMLS CUI [6,2])
C0205191 (UMLS CUI [6,3])
C0456683 (UMLS CUI [6,4])
Life Expectancy
Item
life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group (ecog) performance status <=2 (karnofsky >=60%
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Organ function | Bone Marrow function
Item
must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Patients Inappropriate Curative treatment Locoregional | Recurrent disease Locoregional | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure | Excision Unacceptable
Item
must not be candidates for curative locoregional treatments. patients with recurrent locoregional disease following surgery and/or radiation for who a resection is unacceptably morbid and unlikely to be curative are eligible.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
C1947913 (UMLS CUI [1,4])
C0277556 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C0728940 (UMLS CUI [5,1])
C1883420 (UMLS CUI [5,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Contraception, Barrier | Sexual Abstinence
Item
women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0004764 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin | Adverse drug events Recovery Lacking
Item
have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0041755 (UMLS CUI [5,1])
C2004454 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
Investigational New Drugs
Item
may not be receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastases
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Compound Similar Capecitabine | Allergic Reaction Compound Similar Interferon
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to either capecitabine or interferon
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C2348205 (UMLS CUI [1,3])
C0671970 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C3652465 (UMLS CUI [2,4])
Illness Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled, ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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