ID

44502

Descrição

Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00753038

Link

https://clinicaltrials.gov/show/NCT00753038

Palavras-chave

Versões (2)
  1. 18/11/2017 18/11/2017 -
  2. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Carcinoma, Squamous Cell of the Head and Neck NCT00753038

Inglês

Eligibility Carcinoma, Squamous Cell of the Head and Neck NCT00753038

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
have platinum-refractory metastatic and/or recurrent histologically confirmed stage iii/iv squamous cell carcinoma of the head and neck (oral cavity, larynx or pharynx) with no secondary cancers
Descrição

HEAD NECK CANCER SQUAMOUS CELL METASTATIC TNM clinical staging | HEAD NECK CANCER SQUAMOUS CELL RECURRENT TNM clinical staging | Platinum Unresponsive to Treatment | Oral cavity | Larynx | Pharynx | Secondary Malignant Neoplasm Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0744620
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C4524839
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0032207
UMLS CUI [3,2]
C0205269
UMLS CUI [4]
C0226896
UMLS CUI [5]
C0023078
UMLS CUI [6]
C0031354
UMLS CUI [7,1]
C3266877
UMLS CUI [7,2]
C0332197
have evidence of measurable disease
Descrição

Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
have documented progressive disease (pd) on or within 190 days following the completion of treatment of cisplatin-based or carboplatin-based chemotherapy in a recurrent or metastatic setting and if treatment with cetuximab was considered indicated for the patient, documented pd(on or within 190 days of treatment)
Descrição

Progressive Disease | Chemotherapy Cisplatin Based Recurrent disease | Chemotherapy Carboplatin Based Recurrent disease | Chemotherapy Cisplatin Based Neoplasm Metastasis | Chemotherapy Carboplatin Based Neoplasm Metastasis | Cetuximab Indicated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0008838
UMLS CUI [2,3]
C1705938
UMLS CUI [2,4]
C0277556
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0079083
UMLS CUI [3,3]
C1705938
UMLS CUI [3,4]
C0277556
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0008838
UMLS CUI [4,3]
C1705938
UMLS CUI [4,4]
C0027627
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0079083
UMLS CUI [5,3]
C1705938
UMLS CUI [5,4]
C0027627
UMLS CUI [6,1]
C0995188
UMLS CUI [6,2]
C1444656
have no continuing acute toxic effect of any prior radiotherapy, chemotherapy or surgical procedures
Descrição

Toxic effect Absent | Therapeutic radiology procedure | Chemotherapy | Operative Surgical Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0543467
have received no chemotherapy, radiotherapy, immunotherapy or hormonotherapy within 28 days
Descrição

Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent | Hormone Therapy Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C0332197
have ecog performance score of ≤2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
have life expectancy of at least 3 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
absolute neutrophils ≥ 1.5 x10^9/l; platelets ≥100 x10^9; hemoglobin ≥9.0 g/dl; serum creatinine ≤1.5 xuln; bilirubin ≤1.5 x uln; ast/alt ≤2.5xuln
Descrição

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0201976
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
negative pregnancy test for females of childbearing potential
Descrição

Childbearing Potential Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
have known brain metastasis
Descrição

Metastatic malignant neoplasm to brain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
have known bone metastasis
Descrição

Secondary malignant neoplasm of bone

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0153690
be on immunosuppressive therapy; have known hiv infection or active hepatitis b or c
Descrição

Therapeutic immunosuppression | HIV Infection | Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
be a pregnant or breast-feeding woman
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
have clinically significant cardiac disease
Descrição

Heart Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
have dementia or altered mental status that would prohibit informed consent
Descrição

Dementia Preventing Informed Consent | Altered mental state Preventing Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0278061
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
have any other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the principal investigator, would make the patient inappropriate for this study
Descrição

Medical condition Study Subject Participation Status Risk Increased | Medical condition Investigational New Drugs Risk Increased | Medical condition Interferes with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Medical condition Severe | Medical condition chronic | Laboratory test result abnormal Study Subject Participation Status Risk Increased | Laboratory test result abnormal Investigational New Drugs Risk Increased | Laboratory test result abnormal Interferes with Interpretation Research results | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0205217
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0035647
UMLS CUI [2,4]
C0205217
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1548788
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0205191
UMLS CUI [7,1]
C0438215
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C0035647
UMLS CUI [7,4]
C0205217
UMLS CUI [8,1]
C0438215
UMLS CUI [8,2]
C0013230
UMLS CUI [8,3]
C0035647
UMLS CUI [8,4]
C0205217
UMLS CUI [9,1]
C0438215
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0459471
UMLS CUI [9,4]
C0683954
UMLS CUI [10,1]
C0438215
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C1548788
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Similar models

Eligibility Carcinoma, Squamous Cell of the Head and Neck NCT00753038

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
HEAD NECK CANCER SQUAMOUS CELL METASTATIC TNM clinical staging | HEAD NECK CANCER SQUAMOUS CELL RECURRENT TNM clinical staging | Platinum Unresponsive to Treatment | Oral cavity | Larynx | Pharynx | Secondary Malignant Neoplasm Absent
Item
have platinum-refractory metastatic and/or recurrent histologically confirmed stage iii/iv squamous cell carcinoma of the head and neck (oral cavity, larynx or pharynx) with no secondary cancers
boolean
C0744620 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C4524839 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0032207 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0226896 (UMLS CUI [4])
C0023078 (UMLS CUI [5])
C0031354 (UMLS CUI [6])
C3266877 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Measurable Disease
Item
have evidence of measurable disease
boolean
C1513041 (UMLS CUI [1])
Progressive Disease | Chemotherapy Cisplatin Based Recurrent disease | Chemotherapy Carboplatin Based Recurrent disease | Chemotherapy Cisplatin Based Neoplasm Metastasis | Chemotherapy Carboplatin Based Neoplasm Metastasis | Cetuximab Indicated
Item
have documented progressive disease (pd) on or within 190 days following the completion of treatment of cisplatin-based or carboplatin-based chemotherapy in a recurrent or metastatic setting and if treatment with cetuximab was considered indicated for the patient, documented pd(on or within 190 days of treatment)
boolean
C1335499 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0008838 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
C0277556 (UMLS CUI [2,4])
C0392920 (UMLS CUI [3,1])
C0079083 (UMLS CUI [3,2])
C1705938 (UMLS CUI [3,3])
C0277556 (UMLS CUI [3,4])
C0392920 (UMLS CUI [4,1])
C0008838 (UMLS CUI [4,2])
C1705938 (UMLS CUI [4,3])
C0027627 (UMLS CUI [4,4])
C0392920 (UMLS CUI [5,1])
C0079083 (UMLS CUI [5,2])
C1705938 (UMLS CUI [5,3])
C0027627 (UMLS CUI [5,4])
C0995188 (UMLS CUI [6,1])
C1444656 (UMLS CUI [6,2])
Toxic effect Absent | Therapeutic radiology procedure | Chemotherapy | Operative Surgical Procedures
Item
have no continuing acute toxic effect of any prior radiotherapy, chemotherapy or surgical procedures
boolean
C0600688 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent | Hormone Therapy Absent
Item
have received no chemotherapy, radiotherapy, immunotherapy or hormonotherapy within 28 days
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0279025 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
ECOG performance status
Item
have ecog performance score of ≤2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
have life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
absolute neutrophils ≥ 1.5 x10^9/l; platelets ≥100 x10^9; hemoglobin ≥9.0 g/dl; serum creatinine ≤1.5 xuln; bilirubin ≤1.5 x uln; ast/alt ≤2.5xuln
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for females of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
have known brain metastasis
boolean
C0220650 (UMLS CUI [1])
Secondary malignant neoplasm of bone
Item
have known bone metastasis
boolean
C0153690 (UMLS CUI [1])
Therapeutic immunosuppression | HIV Infection | Hepatitis B | Hepatitis C
Item
be on immunosuppressive therapy; have known hiv infection or active hepatitis b or c
boolean
C0021079 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
be a pregnant or breast-feeding woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease
Item
have clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Dementia Preventing Informed Consent | Altered mental state Preventing Informed Consent
Item
have dementia or altered mental status that would prohibit informed consent
boolean
C0497327 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0278061 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Medical condition Study Subject Participation Status Risk Increased | Medical condition Investigational New Drugs Risk Increased | Medical condition Interferes with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Medical condition Severe | Medical condition chronic | Laboratory test result abnormal Study Subject Participation Status Risk Increased | Laboratory test result abnormal Investigational New Drugs Risk Increased | Laboratory test result abnormal Interferes with Interpretation Research results | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
have any other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the principal investigator, would make the patient inappropriate for this study
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0205217 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C0205217 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C3843040 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C0438215 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C0035647 (UMLS CUI [7,3])
C0205217 (UMLS CUI [7,4])
C0438215 (UMLS CUI [8,1])
C0013230 (UMLS CUI [8,2])
C0035647 (UMLS CUI [8,3])
C0205217 (UMLS CUI [8,4])
C0438215 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0459471 (UMLS CUI [9,3])
C0683954 (UMLS CUI [9,4])
C0438215 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1548788 (UMLS CUI [10,3])
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