ID

18512

Beschreibung

FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00086333

Link

https://clinicaltrials.gov/show/NCT00086333

Stichworte

Versionen (1)
  1. 09.11.16 09.11.16 -
Hochgeladen am

9. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Carcinoma NCT00086333

Englisch

Eligibility Non-Small Cell Lung Carcinoma NCT00086333

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with pathologically confirmed stage iiib or iv nsclc with a minimum of 1 measurable baseline target lesion who have received no prior chemotherapy for metastatic disease and are not eligible for combined modality therapy with curative intent
Beschreibung

Non-Small Cell Lung Carcinoma | TNM clinical staging | Measurable Disease Quantity | Prior Chemotherapy Neoplasm Metastasis | Combined Modality Therapy Curative intent

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0027627
UMLS CUI [5,1]
C0009429
UMLS CUI [5,2]
C1276305
patients must have an ecog performance status of less than or equal to 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
-patients must have a tumor block available for documentation of ley antigen expression by immunohistochemistry
Beschreibung

Malignant Neoplasm Block Available | Lewis Y antigen Expression Documentation | Immunohistochemistry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1533157
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0298751
UMLS CUI [2,2]
C0017262
UMLS CUI [2,3]
C0920316
UMLS CUI [3]
C0021044
-fdg-pet imaging must be completed at a pet center approved by seattle genetics
Beschreibung

FDG-Positron Emission Tomography Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3641247
UMLS CUI [1,2]
C0205197
patients must have adequate bone marrow and hepatic function
Beschreibung

Bone Marrow function | Liver function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
-prior cytotoxic therapy for metastatic nsclc
Beschreibung

Cytotoxic therapy Non-small cell lung cancer metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0278987
-those with serious underlying non-malignant disease
Beschreibung

Disease Non-Malignant Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518371
UMLS CUI [1,3]
C0205404
-patients with peripheral neuropathy > grade 2 are excluded from study
Beschreibung

Peripheral Neuropathy | CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
-patients with iddm or niddm
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
patients with known active viral, bacterial, or symptomatic fungal infection
Beschreibung

Virus Diseases | Bacterial Infections | Mycoses Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0042769
UMLS CUI [2]
C0004623
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0231220
concomitant with other antineoplastic or experimental agents
Beschreibung

Antineoplastic Agents | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0013230
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Ähnliche Modelle

Eligibility Non-Small Cell Lung Carcinoma NCT00086333

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | TNM clinical staging | Measurable Disease Quantity | Prior Chemotherapy Neoplasm Metastasis | Combined Modality Therapy Curative intent
Item
patients with pathologically confirmed stage iiib or iv nsclc with a minimum of 1 measurable baseline target lesion who have received no prior chemotherapy for metastatic disease and are not eligible for combined modality therapy with curative intent
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
C1513041 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C0009429 (UMLS CUI [5,1])
C1276305 (UMLS CUI [5,2])
ECOG performance status
Item
patients must have an ecog performance status of less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Malignant Neoplasm Block Available | Lewis Y antigen Expression Documentation | Immunohistochemistry
Item
-patients must have a tumor block available for documentation of ley antigen expression by immunohistochemistry
boolean
C0006826 (UMLS CUI [1,1])
C1533157 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0298751 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0920316 (UMLS CUI [2,3])
C0021044 (UMLS CUI [3])
FDG-Positron Emission Tomography Completed
Item
-fdg-pet imaging must be completed at a pet center approved by seattle genetics
boolean
C3641247 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Bone Marrow function | Liver function
Item
patients must have adequate bone marrow and hepatic function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Cytotoxic therapy Non-small cell lung cancer metastatic
Item
-prior cytotoxic therapy for metastatic nsclc
boolean
C0677881 (UMLS CUI [1,1])
C0278987 (UMLS CUI [1,2])
Disease Non-Malignant Serious
Item
-those with serious underlying non-malignant disease
boolean
C0012634 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
Peripheral Neuropathy | CTCAE Grades
Item
-patients with peripheral neuropathy > grade 2 are excluded from study
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
-patients with iddm or niddm
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Virus Diseases | Bacterial Infections | Mycoses Symptomatic
Item
patients with known active viral, bacterial, or symptomatic fungal infection
boolean
C0042769 (UMLS CUI [1])
C0004623 (UMLS CUI [2])
C0026946 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
Antineoplastic Agents | Investigational New Drugs
Item
concomitant with other antineoplastic or experimental agents
boolean
C0003392 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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