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Informations:
Erreur:
ID
14827
Description
Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12; ODM derived from: https://clinicaltrials.gov/show/NCT00194753
Lien
https://clinicaltrials.gov/show/NCT00194753
Mots-clés
Versions (2)
- 01/05/2016 01/05/2016 -
- 02/05/2016 02/05/2016 - Julian Varghese
Téléchargé le
1 mai 2016
DOI
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Licence
Creative Commons BY-NC 3.0
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Eligibility Breast Neoplasm NCT00194753
Eligibility Breast Neoplasm NCT00194753
- StudyEvent: Eligibility
Similar models
Eligibility Breast Neoplasm NCT00194753
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
ID.1
Item
patient must have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected. (this regimen is not intended for neoadjuvant treatment.)
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1521996 (UMLS CUI [1,4])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1521996 (UMLS CUI [1,4])
ID.2
Item
the attending physician must judge the patient to be an appropriate candidate for adriamycin based adjuvant chemotherapy. appropriate candidates generally include those with stage ii or iii breast cancer. the individual attending physician, however, should make the decision.
boolean
C0085533 (UMLS CUI [1,1])
C0085752 (UMLS CUI [1,2])
C0085752 (UMLS CUI [1,2])
ID.3
Item
tumor her-2/neu expression must be determined prior to study enrollment. assessment may be by fluorescence in situ hybridization (fish) assay or by immunocytochemistry (icc). if determination is "intermediate" by immunocytochemistry, fish must be performed. protocol therapy is determined by her-2/neu result.
boolean
C1512413 (UMLS CUI [1])
ID.4
Item
patient must be at least 18.
boolean
C0001779 (UMLS CUI [1])
ID.5
Item
the patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
ID.6
Item
pre-study hematologic values required for entry onto trial are: wbc greater than= 4,000/mm3, anc greater than= 1,500/mm3 and platelets greater than= 100,000/mm3.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
ID.7
Item
patients with significant renal dysfunction (creatinine greater than 1.5 x institutional upper limit of normal (iuln)) or hepatic dysfunction (C1278039 greater than iuln; transaminases greater than 2.5 x iuln) are not eligible.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
ID.8
Item
except for the following, no prior malignancy is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient has been disease free for 5 years.
boolean
C0006826 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
ID.9
Item
patients with clinically apparent cardiac disease, or history of same, are not eligible. patients who are > 60 years of age or who have a history of hypertension must have a muga prior to enrollment. lvef must be normal.
boolean
C0018799 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0428772 (UMLS CUI [4])
C0020538 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0428772 (UMLS CUI [4])
ID.10
Item
patients who have received prior chemotherapy or radiotherapy are not eligible.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1522449 (UMLS CUI [2])
ID.11
Item
patients who are pregnant or breastfeeding are not eligible. women of child bearing potential must have a serum pregnancy test that is negative and agree to practice adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
ID.12
Item
patients with active infection are not eligible.
boolean
C0009450 (UMLS CUI [1])
ID.13
Item
patients who are known to be infected with hiv, or hepatitis c are not eligible. testing is not required unless there is a high index of clinical suspicion.
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
ID.14
Item
patients suffering from psychiatric impairment are not eligible.
boolean
C0846574 (UMLS CUI [1])
ID.15
Item
patients with known hypersensitivity to trimethoprim or sulfonamides are not eligible.
boolean
C0041041 (UMLS CUI [1])
C0038760 (UMLS CUI [2])
C0038760 (UMLS CUI [2])