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Fehler:
ID
27370
Beschreibung
Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00630110
Link
https://clinicaltrials.gov/show/NCT00630110
Stichworte
Versionen (1)
- 09.11.17 09.11.17 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
9. November 2017
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Cancer NCT00630110
Eligibility Cancer NCT00630110
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Cancer NCT00630110
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age
Item
male and females ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced | Non-Small Cell Lung Carcinoma unresectable TNM clinical staging | Chemotherapy Regimen Quantity | Disease Progression
Item
pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable stage iiib or iv) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
C0205179 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
Adverse event resolved CTCAE Grades | Prior Chemotherapy | Prior surgery | Prior radiation therapy
Item
all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to grade ≤ 2
boolean
C0877248 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2])
C0455610 (UMLS CUI [3])
C0279134 (UMLS CUI [4])
C1514893 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2])
C0455610 (UMLS CUI [3])
C0279134 (UMLS CUI [4])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Chemotherapy | Biological treatment | Immunotherapy | Therapeutic radiology procedure | Operative Surgical Procedures | Investigational New Drugs
Item
administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
Heart Diseases
Item
significant cardiac history
boolean
C0018799 (UMLS CUI [1])
Vascular-Disruption Therapy Tumor
Item
prior treatment with tumor vascular disruptive agents
boolean
C1883526 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,2])
Epilepsy
Item
seizure disorder
boolean
C0014544 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Systemic therapy Patient need for
Item
active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1515119 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1515119 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C
Item
known infection with human immunodeficiency virus (hiv), or active hepatitis a, b, or c
boolean
C0019693 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Hypersensitivity Pharmaceutical Preparations Component
Item
patients with a prior hypersensitivity reaction to product components
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Therapeutic procedure Second Cancer | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C0087111 (UMLS CUI [1,1])
C0751623 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C0751623 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
unwilling or unable to comply with procedures required in this protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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