ID

16523

Beschreibung

Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00087802

Link

https://clinicaltrials.gov/show/NCT00087802

Stichworte

Versionen (1)
  1. 22.07.16 22.07.16 -
Hochgeladen am

22. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00087802

Englisch

Eligibility Carcinoma, Non-Small-Cell Lung NCT00087802

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed, stage iiib or iv nsclc, chemo or other systemic therapy naive
Beschreibung

Non-Small Cell Lung Carcinoma | TNM clinical staging | Chemotherapy | Therapy naive Systemic

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
UMLS CUI [3]
C0392920
UMLS CUI [4,1]
C0919936
UMLS CUI [4,2]
C0205373
one (1) unidimensionally measurable lesion
Beschreibung

Measurable Disease Quantity | Lesion size Dimension One

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0449453
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C0205447
ecog performance status of 0 or 1, no peripheral neuropathy >grade 1
Beschreibung

ECOG performance status | Peripheral Neuropathy Grade

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C0031117
UMLS CUI [2,2]
C0441800
patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.
Beschreibung

Metastatic malignant neoplasm to brain Stable Clinical | Dexamethasone Dose Stable | Cranial Irradiation Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0011777
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0079172
UMLS CUI [3,2]
C0220650
recovery in full from any previous surgical procedure
Beschreibung

Operative Surgical Procedures Complete Recovery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826210
no history of an acute cardiac or cns event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease
Beschreibung

cardiac event | CNS disorder | Congestive heart failure Evidence of | Coronary Artery Disease Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0741923
UMLS CUI [2]
C0007682
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0332120
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0443343
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to any of the 4 study drugs
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
concurrent immunotherapy or participation in any investigational drug study within 4 weeks
Beschreibung

Immunotherapy | Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0013230
serious uncontrolled intercurrent medical or psychiatric illness and organ allograft
Beschreibung

Comorbidity Uncontrolled Serious | Allograft Organ

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0040739
UMLS CUI [2,2]
C0178784
history of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)
Beschreibung

Malignant Neoplasms | Squamous cell carcinoma of skin | Basal cell carcinoma | Carcinoma in situ of uterine cervix | Transitional cell carcinoma of bladder Superficial

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0553723
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0851140
UMLS CUI [5,1]
C0279680
UMLS CUI [5,2]
C0205124
patient is a pregnant or lactating female
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Carcinoma, Non-Small-Cell Lung NCT00087802

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | TNM clinical staging | Chemotherapy | Therapy naive Systemic
Item
newly diagnosed, stage iiib or iv nsclc, chemo or other systemic therapy naive
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0919936 (UMLS CUI [4,1])
C0205373 (UMLS CUI [4,2])
Measurable Disease Quantity | Lesion size Dimension One
Item
one (1) unidimensionally measurable lesion
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0449453 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C0205447 (UMLS CUI [2,3])
ECOG performance status | Peripheral Neuropathy Grade
Item
ecog performance status of 0 or 1, no peripheral neuropathy >grade 1
boolean
C1520224 (UMLS CUI [1])
C0031117 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain Stable Clinical | Dexamethasone Dose Stable | Cranial Irradiation Metastatic malignant neoplasm to brain
Item
patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.
boolean
C0220650 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0011777 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0079172 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
Operative Surgical Procedures Complete Recovery
Item
recovery in full from any previous surgical procedure
boolean
C0543467 (UMLS CUI [1,1])
C2826210 (UMLS CUI [1,2])
cardiac event | CNS disorder | Congestive heart failure Evidence of | Coronary Artery Disease Unstable
Item
no history of an acute cardiac or cns event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease
boolean
C0741923 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs
Item
hypersensitivity to any of the 4 study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Immunotherapy | Study Subject Participation Status | Investigational New Drugs
Item
concurrent immunotherapy or participation in any investigational drug study within 4 weeks
boolean
C0021083 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Comorbidity Uncontrolled Serious | Allograft Organ
Item
serious uncontrolled intercurrent medical or psychiatric illness and organ allograft
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0040739 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
Malignant Neoplasms | Squamous cell carcinoma of skin | Basal cell carcinoma | Carcinoma in situ of uterine cervix | Transitional cell carcinoma of bladder Superficial
Item
history of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)
boolean
C0006826 (UMLS CUI [1])
C0553723 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0279680 (UMLS CUI [5,1])
C0205124 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
patient is a pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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