Informations:
Erreur:
ID
11997
Description
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
Lien
https://clinicaltrials.gov/show/NCT02470065
Mots-clés
Versions (1)
- 31/08/2015 31/08/2015 -
Téléchargé le
31 août 2015
DOI
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Licence
Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT02470065
Eligibility Non Small Cell Lung Cancer NCT02470065
- StudyEvent: Eligibility
Similar models
Eligibility Non Small Cell Lung Cancer NCT02470065
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
diagnosis; NSCLC
Item
histological or cytological diagnosis of nsclc;
boolean
C0011900 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
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])
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])
C0022885 (UMLS CUI [2])
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])
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])