ID

36648

Beskrivning

Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02407366

Länk

https://clinicaltrials.gov/show/NCT02407366

Nyckelord

Versioner (1)
  1. 2019-05-28 2019-05-28 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

28 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02407366

Engelsk

Eligibility Non-small Cell Lung Cancer NCT02407366

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. unresectable stage iiia / iiib non-small cell lung cancer with egfr 19/21 mutation.
Beskrivning

Non-Small Cell Lung Carcinoma unresectable TNM clinical staging | EGFR Exon 19 Mutation | EGFR Exon 21 Mutation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C4289656
UMLS CUI [3]
C4289654
2. no previous systemic anticancer therapy.
Beskrivning

Cancer treatment Systemic Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332197
3. life expectancy more than three months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
4. ecog performance status of 0 to 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. measurable lesion according to recist with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
Beskrivning

Measurable lesion | Prior radiation therapy Absent Measurable lesion Quantity | Exception Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1513041
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0242656
6. patients will be required to provide informed consent before enrollment.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
Beskrivning

Neoplasm Metastasis Intrapulmonary | Atelectasis Entire hemithorax | Dissemination Pleural | Neoplasm Metastasis Hilar lymph node Contralateral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442121
UMLS CUI [2,1]
C0004144
UMLS CUI [2,2]
C1269692
UMLS CUI [3,1]
C0205221
UMLS CUI [3,2]
C1522720
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C1305372
UMLS CUI [4,3]
C0441988
2. prior chemotherapy for nsclc, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
Beskrivning

Prior Chemotherapy Non-Small Cell Lung Carcinoma | Radiotherapy to thorax | Targeted Therapy EGFR signaling pathway

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [2]
C4038705
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C1155379
3. severe heart disease, uncontrolled diabetes mellitus, or active infection.
Beskrivning

Heart Disease Severe | Diabetic - poor control | Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0009450
4. active concomitant malignancy, and pregnancy or breast-feeding.
Beskrivning

Second Primary Cancer | Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02407366

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma unresectable TNM clinical staging | EGFR Exon 19 Mutation | EGFR Exon 21 Mutation
Item
1. unresectable stage iiia / iiib non-small cell lung cancer with egfr 19/21 mutation.
boolean
C0007131 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C4289656 (UMLS CUI [2])
C4289654 (UMLS CUI [3])
Cancer treatment Systemic Absent
Item
2. no previous systemic anticancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Life Expectancy
Item
3. life expectancy more than three months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status of 0 to 1.
boolean
C1520224 (UMLS CUI [1])
Measurable lesion | Prior radiation therapy Absent Measurable lesion Quantity | Exception Disease Progression
Item
5. measurable lesion according to recist with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
boolean
C1513041 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0242656 (UMLS CUI [3,2])
Informed Consent
Item
6. patients will be required to provide informed consent before enrollment.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Intrapulmonary | Atelectasis Entire hemithorax | Dissemination Pleural | Neoplasm Metastasis Hilar lymph node Contralateral
Item
1. intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
boolean
C0027627 (UMLS CUI [1,1])
C0442121 (UMLS CUI [1,2])
C0004144 (UMLS CUI [2,1])
C1269692 (UMLS CUI [2,2])
C0205221 (UMLS CUI [3,1])
C1522720 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C1305372 (UMLS CUI [4,2])
C0441988 (UMLS CUI [4,3])
Prior Chemotherapy Non-Small Cell Lung Carcinoma | Radiotherapy to thorax | Targeted Therapy EGFR signaling pathway
Item
2. prior chemotherapy for nsclc, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C4038705 (UMLS CUI [2])
C2985566 (UMLS CUI [3,1])
C1155379 (UMLS CUI [3,2])
Heart Disease Severe | Diabetic - poor control | Communicable Diseases
Item
3. severe heart disease, uncontrolled diabetes mellitus, or active infection.
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
Second Primary Cancer | Pregnancy | Breast Feeding
Item
4. active concomitant malignancy, and pregnancy or breast-feeding.
boolean
C0751623 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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