ID

31080

Beschrijving

Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00770588

Link

https://clinicaltrials.gov/show/NCT00770588

Trefwoorden

Versies (1)
  1. 19-07-18 19-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer (NSCLC) NCT00770588

Engels

Eligibility Non-small Cell Lung Cancer (NSCLC) NCT00770588

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed locally advanced or metastatic (stage=iiib/iv) non-small cell lung cancer (nsclc) before the front line chemotherapy. note: sputum cytology alone is not acceptable
Beschrijving

Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | First line Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C1708063
UMLS CUI [3,2]
C0392920
patients have completed 4 cycles of first line platinum contained doublet chemotherapy without progression or intolerable toxicity.
Beschrijving

First line treatment Chemotherapy cycle Quantity | Chemotherapy Double Containing Platinum | Disease Progression Absent | Toxicity Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1302181
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205173
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0032207
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0332197
patients with pr or sd on study entry need to have one or more measurable lesions according to recist criteria.
Beschrijving

Partial response | Stable Disease | Measurable lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C1521726
UMLS CUI [2]
C0677946
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C1265611
the study treatment should be started at least 3 weeks (21 days) but no more than 6 weeks (42 days) since last dose of chemotherapy, and within 4 weeks (28 days) since last tumour assessment.
Beschrijving

Clinical Trial Therapeutic procedure Start time | Chemotherapy | Tumor Assessment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1301880
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C1516048
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to monoclonal antibodies or small molecule inhibitors against egfr receptors. (e.g. gefitinib, erlotinib, c225)
Beschrijving

Exposure to Anti-EGFR Monoclonal Antibody | Exposure to Small Molecule Inhibitors | Small Molecule Inhibitors Against EGFR | gefitinib | erlotinib | C225

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C4522190
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C1328819
UMLS CUI [2,3]
C0243077
UMLS CUI [3,1]
C1328819
UMLS CUI [3,2]
C0243077
UMLS CUI [3,3]
C0521124
UMLS CUI [3,4]
C0034802
UMLS CUI [4]
C1122962
UMLS CUI [5]
C1135135
UMLS CUI [6]
C0879636
patients with previously diagnosed and treated cns metastases or spinal cord compression may be considered if they are clinically stable and have been discontinued from steroid therapy for at least 4 weeks prior to first dose of study medication.
Beschrijving

CNS metastases Treated | Compression of spinal cord Treated | Stable status Clinical | Steroid therapy Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0037926
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0205360
UMLS CUI [3,2]
C0205210
UMLS CUI [4,1]
C0149783
UMLS CUI [4,2]
C1444662
any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
Beschrijving

Lung Diseases, Interstitial

Datatype

boolean

Alias
UMLS CUI [1]
C0206062
known biomarker status of one or more of the following: tumour egfr gene copy number, tumour egfr gene mutation status, tumour egfr protein expression.
Beschrijving

Biological Markers Status Known | Neoplasm EGFR Gene copy number | Neoplasm EGFR Gene Mutation Status | Neoplasm EGFR Protein expression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005516
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205309
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0034802
UMLS CUI [2,3]
C0178655
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0034802
UMLS CUI [3,3]
C0596611
UMLS CUI [3,4]
C0449438
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C0034802
UMLS CUI [4,3]
C1171362
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Similar models

Eligibility Non-small Cell Lung Cancer (NSCLC) NCT00770588

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | First line Chemotherapy
Item
histologically or cytologically confirmed locally advanced or metastatic (stage=iiib/iv) non-small cell lung cancer (nsclc) before the front line chemotherapy. note: sputum cytology alone is not acceptable
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C1708063 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
First line treatment Chemotherapy cycle Quantity | Chemotherapy Double Containing Platinum | Disease Progression Absent | Toxicity Absent
Item
patients have completed 4 cycles of first line platinum contained doublet chemotherapy without progression or intolerable toxicity.
boolean
C1708063 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0032207 (UMLS CUI [2,4])
C0242656 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0600688 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Partial response | Stable Disease | Measurable lesion Quantity
Item
patients with pr or sd on study entry need to have one or more measurable lesions according to recist criteria.
boolean
C1521726 (UMLS CUI [1])
C0677946 (UMLS CUI [2])
C1513041 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Clinical Trial Therapeutic procedure Start time | Chemotherapy | Tumor Assessment
Item
the study treatment should be started at least 3 weeks (21 days) but no more than 6 weeks (42 days) since last dose of chemotherapy, and within 4 weeks (28 days) since last tumour assessment.
boolean
C0008976 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C0027651 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Exposure to Anti-EGFR Monoclonal Antibody | Exposure to Small Molecule Inhibitors | Small Molecule Inhibitors Against EGFR | gefitinib | erlotinib | C225
Item
prior exposure to monoclonal antibodies or small molecule inhibitors against egfr receptors. (e.g. gefitinib, erlotinib, c225)
boolean
C0332157 (UMLS CUI [1,1])
C4522190 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1328819 (UMLS CUI [2,2])
C0243077 (UMLS CUI [2,3])
C1328819 (UMLS CUI [3,1])
C0243077 (UMLS CUI [3,2])
C0521124 (UMLS CUI [3,3])
C0034802 (UMLS CUI [3,4])
C1122962 (UMLS CUI [4])
C1135135 (UMLS CUI [5])
C0879636 (UMLS CUI [6])
CNS metastases Treated | Compression of spinal cord Treated | Stable status Clinical | Steroid therapy Discontinued
Item
patients with previously diagnosed and treated cns metastases or spinal cord compression may be considered if they are clinically stable and have been discontinued from steroid therapy for at least 4 weeks prior to first dose of study medication.
boolean
C0686377 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0037926 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205360 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0149783 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Lung Diseases, Interstitial
Item
any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
boolean
C0206062 (UMLS CUI [1])
Biological Markers Status Known | Neoplasm EGFR Gene copy number | Neoplasm EGFR Gene Mutation Status | Neoplasm EGFR Protein expression
Item
known biomarker status of one or more of the following: tumour egfr gene copy number, tumour egfr gene mutation status, tumour egfr protein expression.
boolean
C0005516 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0034802 (UMLS CUI [2,2])
C0178655 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C0034802 (UMLS CUI [3,2])
C0596611 (UMLS CUI [3,3])
C0449438 (UMLS CUI [3,4])
C0027651 (UMLS CUI [4,1])
C0034802 (UMLS CUI [4,2])
C1171362 (UMLS CUI [4,3])
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