ID

11997

Beskrivning

Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT02470065 Principal Investigator: Sanjay Popat, PhD Royal Marsden NHS Foundation Trust

Länk

https://clinicaltrials.gov/show/NCT02470065

Nyckelord

Versioner (1)
  1. 2015-08-31 2015-08-31 -
Uppladdad den

31 augusti 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT02470065

Engelsk

Eligibility Non Small Cell Lung Cancer NCT02470065

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
histological or cytological diagnosis of nsclc;
Beskrivning

diagnosis; NSCLC

Datatyp

boolean

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0007131
Patients considered operable and with resectable tumor with curative intent (anatomical resection and systematic lymph node dissection) based on evaluation by a thoracic multi-disciplinary team composed of at least a thoracic surgeon, oncologist and radiologist;
Beskrivning

Patients considered operable and with resectable tumor with curative intent (anatomical resection and systematic lymph node dissection) based on evaluation by a thoracic multi-disciplinary team composed of at least a thoracic surgeon, oncologist and radiologist;

Datatyp

boolean

Alias
UMLS CUI [1]
C1273390
UMLS CUI [2]
C0027651
Stage I-III (T1a-3, N0-1, M0 according to UICC version 7) NSCLC by local staging criteria potentially treatable by radical (curative) surgery. Patients with T1 tumor at baseline will be limited to 20%;
Beskrivning

Stage I-III (T1a-3, N0-1, M0 according to UICC version 7) NSCLC by local staging criteria potentially treatable by radical (curative) surgery. Patients with T1 tumor at baseline will be limited to 20%;

Datatyp

boolean

Alias
UMLS CUI [1]
C0178759
Radiologically measurable disease according to RECIST criteria 1.1; assessed by chest and upper abdomen CT scan within 2 weeks (+1 week) prior to registration); brain CT scan or MRI according to local practice
Beskrivning

Radiologically measurable disease according to RECIST criteria 1.1; assessed by chest and upper abdomen CT scan within 2 weeks (+1 week) prior to registration); brain CT scan or MRI according to local practice

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
No prior treatment for NSCLC is allowed
Beskrivning

prior treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
Adequate tissue in terms of quality and quantity for EGFR local testing.
Beskrivning

Adequate tissue in terms of quality and quantity for EGFR local testing.

Datatyp

boolean

Alias
UMLS CUI [1]
C0034802
UMLS CUI [2]
C0022885
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
no adequate bone marrow function within 2 weeks prior to randomization
Beskrivning

no adequate bone marrow function within 2 weeks prior to randomization

Datatyp

boolean

Alias
UMLS CUI [1]
C1389329
no adequate liver function. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal; within 2 weeks prior to randomization
Beskrivning

no adequate liver function. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal; within 2 weeks prior to randomization

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
no adequate renal function within 2 weeks prior to randomization
Beskrivning

no adequate renal function within 2 weeks prior to randomization

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
known positivity to human immunodeficiency virus (hiv), hepatitis b or hepatitis c
Beskrivning

known positivity to human immunodeficiency virus (HIV), hepatitis B or hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019158
known history of allergic reactions attributed to compounds of similar chemical or biological composition;
Beskrivning

known history of allergic reactions attributed to compounds of similar chemical or biological composition

Datatyp

boolean

Alias
UMLS CUI [1]
C1527304
history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years, except pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanoma skin cancer or carcinoma in situ of the cervix;
Beskrivning

history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years, except pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanoma skin cancer or carcinoma in situ of the cervix;

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Non Small Cell Lung Cancer NCT02470065

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
diagnosis; NSCLC
Item
histological or cytological diagnosis of nsclc;
boolean
C0011900 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
curative treatment; Neoplasms
Item
Patients considered operable and with resectable tumor with curative intent (anatomical resection and systematic lymph node dissection) based on evaluation by a thoracic multi-disciplinary team composed of at least a thoracic surgeon, oncologist and radiologist;
boolean
C1273390 (UMLS CUI [1])
C0027651 (UMLS CUI [2])
Tumor Stage Classification
Item
Stage I-III (T1a-3, N0-1, M0 according to UICC version 7) NSCLC by local staging criteria potentially treatable by radical (curative) surgery. Patients with T1 tumor at baseline will be limited to 20%;
boolean
C0178759 (UMLS CUI [1])
measurable disease
Item
Radiologically measurable disease according to RECIST criteria 1.1; assessed by chest and upper abdomen CT scan within 2 weeks (+1 week) prior to registration); brain CT scan or MRI according to local practice
boolean
C1513041 (UMLS CUI [1])
prior treatment
Item
No prior treatment for NSCLC is allowed
boolean
C1514463 (UMLS CUI [1])
Epidermal Growth Factor Receptor; test
Item
Adequate tissue in terms of quality and quantity for EGFR local testing.
boolean
C0034802 (UMLS CUI [1])
C0022885 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
poor function; bone marrow
Item
no adequate bone marrow function within 2 weeks prior to randomization
boolean
C1389329 (UMLS CUI [1])
liver function
Item
no adequate liver function. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal; within 2 weeks prior to randomization
boolean
C0232741 (UMLS CUI [1])
renal function
Item
no adequate renal function within 2 weeks prior to randomization
boolean
C0232804 (UMLS CUI [1])
HIV positive; Hepatitis
Item
known positivity to human immunodeficiency virus (hiv), hepatitis b or hepatitis c
boolean
C0019699 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
allergic reaction
Item
known history of allergic reactions attributed to compounds of similar chemical or biological composition;
boolean
C1527304 (UMLS CUI [1])
Malignant Neoplasms
Item
history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years, except pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanoma skin cancer or carcinoma in situ of the cervix;
boolean
C0006826 (UMLS CUI [1])
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