ID

18529

Description

Iressa Versus Docetaxel (Taxotere); ODM derived from: https://clinicaltrials.gov/show/NCT00076388

Link

https://clinicaltrials.gov/show/NCT00076388

Keywords

Versions (1)
  1. 11/9/16 11/9/16 -
Uploaded on

November 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Carcinoma NCT00076388

English

Eligibility Non-Small-Cell Lung Carcinoma NCT00076388

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
measurable (uni dimensional) disease by recist criteria in a lesion not previously irradiated or non measurable disease
Description

Measurable Disease Linear | prior radiation therapy Lesion | Non-Measurable Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0221198
UMLS CUI [3]
C1334988
locally advanced or metastatic nsclc, not amenable to curative surgery or radiotherapy
Description

Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Disease Amenable Curative Surgery | Disease Amenable Therapeutic radiology procedure Curative

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0278987
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C3900053
UMLS CUI [3,3]
C1511562
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C3900053
UMLS CUI [4,3]
C1522449
UMLS CUI [4,4]
C1276305
advanced non-small cell lung cancer (nsclc) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
Description

Non-Small Cell Lung Carcinoma Advanced | Prior Chemotherapy Platinum-Based | Recurrence | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1514162
UMLS CUI [3]
C2825055
UMLS CUI [4]
C0242656
who performance status (ps) 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
absolute neutrophil count (anc) >1.5 x 109/liter (l) and platelets >100 x 109/l
Description

Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
life expectancy of at least 8 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior zd1839 therapy
Description

ZD1839

Data type

boolean

Alias
UMLS CUI [1]
C0879396
prior docetaxel treatment for nsclc
Description

docetaxel Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0007131
less than 14 days since completion of prior radiotherapy
Description

prior radiation therapy Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205197
less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
Description

Prior Chemotherapy | Prior Immunotherapy | cancer treatment Systemic biological

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C1514461
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C0205460
evidence of clinically active interstitial lung disease
Description

Interstitial Lung Disease Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C0332120
other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Description

Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
newly diagnosed cns metastases that have not yet been treated with surgery and/or radiation. patients with previously diagnosed and treated cns metastases or spinal cord compression may be considered if they have evidence of clinically sd (no steroid therapy or steroid dose being tapered) for at least 28 days
Description

CNS metastases | Operative Surgical Procedures | Therapeutic radiology procedure | CNS metastases Treated | Compression of spinal cord Treated | Stable Disease Clinical Evidence of | Steroid therapy | Steroids Dose Tapered

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C0686377
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0037926
UMLS CUI [5,2]
C1522326
UMLS CUI [6,1]
C0677946
UMLS CUI [6,2]
C0205210
UMLS CUI [6,3]
C0332120
UMLS CUI [7]
C0149783
UMLS CUI [8,1]
C0038317
UMLS CUI [8,2]
C2348006
patients with pre existing peripheral neuropathy >= grade 2 (nci ctc criteria)
Description

Peripheral Neuropathy Pre-existing | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C1516728
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Similar models

Eligibility Non-Small-Cell Lung Carcinoma NCT00076388

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Measurable Disease Linear | prior radiation therapy Lesion | Non-Measurable Lesion
Item
measurable (uni dimensional) disease by recist criteria in a lesion not previously irradiated or non measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C1334988 (UMLS CUI [3])
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Disease Amenable Curative Surgery | Disease Amenable Therapeutic radiology procedure Curative
Item
locally advanced or metastatic nsclc, not amenable to curative surgery or radiotherapy
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C3900053 (UMLS CUI [3,2])
C1511562 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C3900053 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
C1276305 (UMLS CUI [4,4])
Non-Small Cell Lung Carcinoma Advanced | Prior Chemotherapy Platinum-Based | Recurrence | Disease Progression
Item
advanced non-small cell lung cancer (nsclc) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C2825055 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
WHO performance status scale
Item
who performance status (ps) 0-2
boolean
C1298650 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement
Item
absolute neutrophil count (anc) >1.5 x 109/liter (l) and platelets >100 x 109/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of at least 8 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ZD1839
Item
prior zd1839 therapy
boolean
C0879396 (UMLS CUI [1])
docetaxel Non-Small Cell Lung Carcinoma
Item
prior docetaxel treatment for nsclc
boolean
C0246415 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
prior radiation therapy Complete
Item
less than 14 days since completion of prior radiotherapy
boolean
C0279134 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Prior Chemotherapy | Prior Immunotherapy | cancer treatment Systemic biological
Item
less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
boolean
C1514457 (UMLS CUI [1])
C1514461 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0205460 (UMLS CUI [3,3])
Interstitial Lung Disease Evidence of
Item
evidence of clinically active interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
CNS metastases | Operative Surgical Procedures | Therapeutic radiology procedure | CNS metastases Treated | Compression of spinal cord Treated | Stable Disease Clinical Evidence of | Steroid therapy | Steroids Dose Tapered
Item
newly diagnosed cns metastases that have not yet been treated with surgery and/or radiation. patients with previously diagnosed and treated cns metastases or spinal cord compression may be considered if they have evidence of clinically sd (no steroid therapy or steroid dose being tapered) for at least 28 days
boolean
C0686377 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0686377 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0037926 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
C0677946 (UMLS CUI [6,1])
C0205210 (UMLS CUI [6,2])
C0332120 (UMLS CUI [6,3])
C0149783 (UMLS CUI [7])
C0038317 (UMLS CUI [8,1])
C2348006 (UMLS CUI [8,2])
Peripheral Neuropathy Pre-existing | CTCAE Grades
Item
patients with pre existing peripheral neuropathy >= grade 2 (nci ctc criteria)
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [2])
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