ID

32575

Descrição

Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01025089

Link

https://clinicaltrials.gov/show/NCT01025089

Palavras-chave

Versões (1)
  1. 07/11/2018 07/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Thymoma NCT01025089

Inglês

Eligibility Thymoma NCT01025089

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Thymoma NCT01025089
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age>18
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status (kps) ≥ 70
Descrição

Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
newly diagnosed or recurrent thymoma - who a, ab, b1, b2, or b340, or thymic carcinoma pathologically confirmed at mskcc, mdacc or city of hope
Descrição

Thymoma Newly Diagnosed WHO tumor classification | Thymoma malignant recurrent WHO tumor classification | Thymic Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040100
UMLS CUI [1,2]
C1518321
UMLS CUI [1,3]
C1301142
UMLS CUI [2,1]
C0278848
UMLS CUI [2,2]
C1301142
UMLS CUI [3]
C0205969
no prior chemotherapy, radiotherapy, or surgical therapy (other than for diagnostic biopsy) for thymoma
Descrição

Absence Prior Chemotherapy Thymoma | Absence Prior radiation therapy Thymoma | Absence Operative Surgical Procedures Thymoma | Exception Biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C0040100
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0279134
UMLS CUI [2,3]
C0040100
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0040100
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0005558
no prior treatment with cetuximab
Descrição

Cetuximab Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0995188
UMLS CUI [1,2]
C0332197
clinical masaoka stage ii (>5cm), iii, or iva(see appendix b), including suspected invasion of mediastinum, pericardium, lung, great vessels or chest wall, and/or pleural metastases normal marrow function: leukocytes ≥ 4,000/μl, absolute neutrophil count ≥ 1,500/μl, platelets ≥ 160,000/μl
Descrição

Masaoka Staging System | Tumor Invasion Suspected Mediastinum | Tumor Invasion Suspected Pericardium | Tumor Invasion Suspected Lung | Tumor Invasion Suspected Great vessels | Tumor Invasion Suspected Chest wall | Secondary malignant neoplasm of pleura | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3827366
UMLS CUI [2,1]
C1269955
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0025066
UMLS CUI [3,1]
C1269955
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0031050
UMLS CUI [4,1]
C1269955
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0024109
UMLS CUI [5,1]
C1269955
UMLS CUI [5,2]
C0750491
UMLS CUI [5,3]
C0225991
UMLS CUI [6,1]
C1269955
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C0205076
UMLS CUI [7]
C0153678
UMLS CUI [8,1]
C0005953
UMLS CUI [8,2]
C0031843
UMLS CUI [9]
C0023508
UMLS CUI [10]
C0948762
UMLS CUI [11]
C0032181
adequate renal function, with creatinine ≤ 1.3 mg/dl or calculated creatinine clearance ≥60ml/min by cockcroft and gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
Descrição

Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
adequate hepatic function: total bilirubin ≤1.5 mg/dl, ast ≤1.5x unl, alkaline phosphatase ≤1.5 un
Descrição

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201850
signed informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
effective contraception
Descrição

Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
medically operable
Descrição

Operable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0205188
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of distant metastatic disease (masaoka stage ivb)
Descrição

Distant metastasis Masaoka Staging System

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C3827366
thymic carcinoid
Descrição

Thymic Carcinoid

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1336746
patients must not be receiving any other investigational agents
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
concurrent or prior malignancy in the last 5 years other than non-melanoma skin cancer and in-situ carcinoma of the cervix
Descrição

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
known hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs. patients on medications known to alter cyp3a4
Descrição

Antiretroviral therapy Combination HIV Seropositivity | Drug Interactions Investigational New Drugs | Pharmaceutical Preparations Changing CYP3A4

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1963724
UMLS CUI [1,2]
C0205195
UMLS CUI [1,3]
C0019699
UMLS CUI [2,1]
C0687133
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C3714798
pregnant or breastfeeding women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Eligibility Thymoma NCT01025089

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Thymoma NCT01025089
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age>18
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status (kps) ≥ 70
boolean
C0206065 (UMLS CUI [1])
Thymoma Newly Diagnosed WHO tumor classification | Thymoma malignant recurrent WHO tumor classification | Thymic Carcinoma
Item
newly diagnosed or recurrent thymoma - who a, ab, b1, b2, or b340, or thymic carcinoma pathologically confirmed at mskcc, mdacc or city of hope
boolean
C0040100 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C1301142 (UMLS CUI [1,3])
C0278848 (UMLS CUI [2,1])
C1301142 (UMLS CUI [2,2])
C0205969 (UMLS CUI [3])
Absence Prior Chemotherapy Thymoma | Absence Prior radiation therapy Thymoma | Absence Operative Surgical Procedures Thymoma | Exception Biopsy
Item
no prior chemotherapy, radiotherapy, or surgical therapy (other than for diagnostic biopsy) for thymoma
boolean
C0332197 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0040100 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0279134 (UMLS CUI [2,2])
C0040100 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0040100 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
Cetuximab Absent
Item
no prior treatment with cetuximab
boolean
C0995188 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Masaoka Staging System | Tumor Invasion Suspected Mediastinum | Tumor Invasion Suspected Pericardium | Tumor Invasion Suspected Lung | Tumor Invasion Suspected Great vessels | Tumor Invasion Suspected Chest wall | Secondary malignant neoplasm of pleura | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
clinical masaoka stage ii (>5cm), iii, or iva(see appendix b), including suspected invasion of mediastinum, pericardium, lung, great vessels or chest wall, and/or pleural metastases normal marrow function: leukocytes ≥ 4,000/μl, absolute neutrophil count ≥ 1,500/μl, platelets ≥ 160,000/μl
boolean
C3827366 (UMLS CUI [1])
C1269955 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0025066 (UMLS CUI [2,3])
C1269955 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0031050 (UMLS CUI [3,3])
C1269955 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0024109 (UMLS CUI [4,3])
C1269955 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0225991 (UMLS CUI [5,3])
C1269955 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0205076 (UMLS CUI [6,3])
C0153678 (UMLS CUI [7])
C0005953 (UMLS CUI [8,1])
C0031843 (UMLS CUI [8,2])
C0023508 (UMLS CUI [9])
C0948762 (UMLS CUI [10])
C0032181 (UMLS CUI [11])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
adequate renal function, with creatinine ≤ 1.3 mg/dl or calculated creatinine clearance ≥60ml/min by cockcroft and gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement
Item
adequate hepatic function: total bilirubin ≤1.5 mg/dl, ast ≤1.5x unl, alkaline phosphatase ≤1.5 un
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods
Item
effective contraception
boolean
C0700589 (UMLS CUI [1])
Operable
Item
medically operable
boolean
C0205188 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Distant metastasis Masaoka Staging System
Item
evidence of distant metastatic disease (masaoka stage ivb)
boolean
C1269798 (UMLS CUI [1,1])
C3827366 (UMLS CUI [1,2])
Thymic Carcinoid
Item
thymic carcinoid
boolean
C1336746 (UMLS CUI [1])
Investigational New Drugs
Item
patients must not be receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
concurrent or prior malignancy in the last 5 years other than non-melanoma skin cancer and in-situ carcinoma of the cervix
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Antiretroviral therapy Combination HIV Seropositivity | Drug Interactions Investigational New Drugs | Pharmaceutical Preparations Changing CYP3A4
Item
known hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs. patients on medications known to alter cyp3a4
boolean
C1963724 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0019699 (UMLS CUI [1,3])
C0687133 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C3714798 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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