ID

32575

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01025089

Nyckelord

Versioner (1)
  1. 2018-11-07 2018-11-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 november 2018

DOI

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Creative Commons BY 4.0
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Eligibility Thymoma NCT01025089

Engelsk

Eligibility Thymoma NCT01025089

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Thymoma NCT01025089
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age>18
Beskrivning

Age

Datatyp

boolean

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

Karnofsky Performance Status

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Cetuximab Absent

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
effective contraception
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
medically operable
Beskrivning

Operable

Datatyp

boolean

Alias
UMLS CUI [1]
C0205188
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Distant metastasis Masaoka Staging System

Datatyp

boolean

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

Thymic Carcinoid

Datatyp

boolean

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

Investigational New Drugs

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

Eligibility Thymoma NCT01025089

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Thymoma NCT01025089
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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