ID

36997

Descrição

Reirradiation With MK-3475 in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT02289209

Link

https://clinicaltrials.gov/show/NCT02289209

Palavras-chave

Versões (1)
  1. 27/06/2019 27/06/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 juin 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Recurrent Head and Neck Cancer NCT02289209

Inglês

Eligibility Recurrent Head and Neck Cancer NCT02289209

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
locoregional inoperable recurrent or second primary squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx)
Descrição

Recurrent Head and Neck Squamous Cell Carcinoma Locoregional Inoperable | Squamous cell carcinoma of the head and neck Second Primary | Oral cavity | Oropharynx | Larynx | Hypopharynx

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4524839
UMLS CUI [1,2]
C1947913
UMLS CUI [1,3]
C0205187
UMLS CUI [2,1]
C1168401
UMLS CUI [2,2]
C0205436
UMLS CUI [2,3]
C0205225
UMLS CUI [3]
C0226896
UMLS CUI [4]
C0521367
UMLS CUI [5]
C0023078
UMLS CUI [6]
C0020629
have had only one prior course of radiation therapy with a curative intent and it has been at least 6 months since completion of radiation
Descrição

Prior radiation therapy Curative Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1276305
UMLS CUI [1,3]
C1265611
based on prior radiation records, have had most of the tumor volume (>50%) previously radiated at doses > 45 gy without exceeding spinal cord tolerance (combining previous and future radiation dose to spinal cord of < 50 gy).
Descrição

Prior radiation therapy Dose Tumor Volume Percentage | Therapeutic radiology procedure Limited Spinal Cord

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0475276
UMLS CUI [1,4]
C0439165
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0037925
be willing to undergo percutaneous endoscopic gastrostomy (peg) placement, if necessary.
Descrição

Percutaneous endoscopic gastrostomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0176751
have at least one measurable area of disease based on recist 1.1 within the previously radiated field.
Descrição

Measurable Disease Within Radiation Field

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C1882536
have provided adequate tissue for pd-l1 analysis either from an archival tissue sample or fresh biopsy done to confirm recurrence/second primary. archival tissue sample can only be used if done within 3 months of enrollment on the clinical trial.
Descrição

Tissue specimen PD-L1 Analysis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0965245
UMLS CUI [1,3]
C0002778
performance status of 0 or 1 on the ecog performance scale.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy greater than 12 weeks
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
adequate organ function based on laboratory results
Descrição

Organ function Laboratory Results

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C1254595
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of distant metastatic disease.
Descrição

Distant metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1269798
has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Descrição

Immunodeficiency | Steroid therapy Systemic | Therapeutic immunosuppression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0021079
| C1705847 history of other malignancy within 5 years with the exception of prior squamous cell carcinoma of the head and neck, adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix.
Descrição

Cancer Other | Exception Squamous cell carcinoma of the head and neck | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Cervix carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1168401
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0302592
has an active autoimmune disease
Descrição

Autoimmune Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
has evidence of interstitial lung disease or active, non-infectious pneumonitis.
Descrição

Lung Diseases, Interstitial | Non-infectious pneumonia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C0264376
is pregnant or breastfeeding.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
has received prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways).
Descrição

Prior Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibodies | CD137 Monoclonal Antibodies | Anti-CTLA-4 Monoclonal Antibody | ipilimumab | Antibodies Targeting T-Lymphocyte | Pharmaceutical Preparations Targeting T-Lymphocyte

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C4289970
UMLS CUI [3]
C4289971
UMLS CUI [4,1]
C1705357
UMLS CUI [4,2]
C0003250
UMLS CUI [5,1]
C0214721
UMLS CUI [5,2]
C0003250
UMLS CUI [6]
C4289973
UMLS CUI [7]
C1367202
UMLS CUI [8,1]
C0003241
UMLS CUI [8,2]
C1521840
UMLS CUI [8,3]
C0039194
UMLS CUI [9,1]
C0013227
UMLS CUI [9,2]
C1521840
UMLS CUI [9,3]
C0039194
has a known history of human immunodeficiency virus (hiv) (hiv 1/2 antibodies).
Descrição

HIV Infection | HIV-1 Antibody Measurement | HIV-2 Antibody Measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0373916
UMLS CUI [3]
C0373917
has known active hepatitis b (e.g., hbsag reactive) or hepatitis c (e.g., hcv rna [qualitative] is detected).
Descrição

Hepatitis B | Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C virus RNA Detected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0019196
UMLS CUI [4,1]
C0369335
UMLS CUI [4,2]
C0442726
has received a live vaccine within 30 days prior to the first dose of trial treatment
Descrição

Vaccines, Attenuated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042211
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Similar models

Eligibility Recurrent Head and Neck Cancer NCT02289209

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Head and Neck Squamous Cell Carcinoma Locoregional Inoperable | Squamous cell carcinoma of the head and neck Second Primary | Oral cavity | Oropharynx | Larynx | Hypopharynx
Item
locoregional inoperable recurrent or second primary squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx)
boolean
C4524839 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C0205187 (UMLS CUI [1,3])
C1168401 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
C0226896 (UMLS CUI [3])
C0521367 (UMLS CUI [4])
C0023078 (UMLS CUI [5])
C0020629 (UMLS CUI [6])
Prior radiation therapy Curative Quantity
Item
have had only one prior course of radiation therapy with a curative intent and it has been at least 6 months since completion of radiation
boolean
C0279134 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Prior radiation therapy Dose Tumor Volume Percentage | Therapeutic radiology procedure Limited Spinal Cord
Item
based on prior radiation records, have had most of the tumor volume (>50%) previously radiated at doses > 45 gy without exceeding spinal cord tolerance (combining previous and future radiation dose to spinal cord of < 50 gy).
boolean
C0279134 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0475276 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C1522449 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0037925 (UMLS CUI [2,3])
Percutaneous endoscopic gastrostomy
Item
be willing to undergo percutaneous endoscopic gastrostomy (peg) placement, if necessary.
boolean
C0176751 (UMLS CUI [1])
Measurable Disease Within Radiation Field
Item
have at least one measurable area of disease based on recist 1.1 within the previously radiated field.
boolean
C1513041 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C1882536 (UMLS CUI [1,3])
Tissue specimen PD-L1 Analysis
Item
have provided adequate tissue for pd-l1 analysis either from an archival tissue sample or fresh biopsy done to confirm recurrence/second primary. archival tissue sample can only be used if done within 3 months of enrollment on the clinical trial.
boolean
C1292533 (UMLS CUI [1,1])
C0965245 (UMLS CUI [1,2])
C0002778 (UMLS CUI [1,3])
ECOG performance status
Item
performance status of 0 or 1 on the ecog performance scale.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Organ function Laboratory Results
Item
adequate organ function based on laboratory results
boolean
C0678852 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Distant metastasis
Item
presence of distant metastatic disease.
boolean
C1269798 (UMLS CUI [1])
Immunodeficiency | Steroid therapy Systemic | Therapeutic immunosuppression
Item
has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
boolean
C0021051 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0021079 (UMLS CUI [3])
Cancer Other | Exception Squamous cell carcinoma of the head and neck | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Cervix carcinoma
Item
| C1705847 history of other malignancy within 5 years with the exception of prior squamous cell carcinoma of the head and neck, adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1168401 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0302592 (UMLS CUI [5,2])
Autoimmune Disease
Item
has an active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Lung Diseases, Interstitial | Non-infectious pneumonia
Item
has evidence of interstitial lung disease or active, non-infectious pneumonitis.
boolean
C0206062 (UMLS CUI [1])
C0264376 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibodies | CD137 Monoclonal Antibodies | Anti-CTLA-4 Monoclonal Antibody | ipilimumab | Antibodies Targeting T-Lymphocyte | Pharmaceutical Preparations Targeting T-Lymphocyte
Item
has received prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways).
boolean
C1514463 (UMLS CUI [1])
C4289970 (UMLS CUI [2])
C4289971 (UMLS CUI [3])
C1705357 (UMLS CUI [4,1])
C0003250 (UMLS CUI [4,2])
C0214721 (UMLS CUI [5,1])
C0003250 (UMLS CUI [5,2])
C4289973 (UMLS CUI [6])
C1367202 (UMLS CUI [7])
C0003241 (UMLS CUI [8,1])
C1521840 (UMLS CUI [8,2])
C0039194 (UMLS CUI [8,3])
C0013227 (UMLS CUI [9,1])
C1521840 (UMLS CUI [9,2])
C0039194 (UMLS CUI [9,3])
HIV Infection | HIV-1 Antibody Measurement | HIV-2 Antibody Measurement
Item
has a known history of human immunodeficiency virus (hiv) (hiv 1/2 antibodies).
boolean
C0019693 (UMLS CUI [1])
C0373916 (UMLS CUI [2])
C0373917 (UMLS CUI [3])
Hepatitis B | Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C virus RNA Detected
Item
has known active hepatitis b (e.g., hbsag reactive) or hepatitis c (e.g., hcv rna [qualitative] is detected).
boolean
C0019163 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0369335 (UMLS CUI [4,1])
C0442726 (UMLS CUI [4,2])
Vaccines, Attenuated
Item
has received a live vaccine within 30 days prior to the first dose of trial treatment
boolean
C0042211 (UMLS CUI [1])
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