Information:
Error:
ID
16587
Description
A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00214864
Link
https://clinicaltrials.gov/show/NCT00214864
Keywords
Versions (1)
- 7/25/16 7/25/16 -
Uploaded on
July 25, 2016
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Metastatic Breast Cancer NCT00214864
Eligibility Metastatic Breast Cancer NCT00214864
- StudyEvent: Eligibility
Similar models
Eligibility Metastatic Breast Cancer NCT00214864
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
metastatic breast cancer
Item
female patients with histopathologically proven metastatic breast cancer.
boolean
C0278488 (UMLS CUI [1])
age
Item
patients 18-75 years old
boolean
C0001779 (UMLS CUI [1])
performance status karnofsky
Item
performance status: karnofsky > 70%
boolean
C0206065 (UMLS CUI [1])
measurable disease
Item
patients must have measurable disease. patients with only blastic bone lesions are ineligible.
boolean
C1513041 (UMLS CUI [1])
comorbidity
Item
adequate bone marrow, liver, renal and cardiac functions defined as:
boolean
C0009488 (UMLS CUI [1])
informed consent
Item
ability to understand the study and give informed consent.
boolean
C0021430 (UMLS CUI [1])
prior chemotherapy
Item
patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-fu or taxol given as part of an adjuvant regimen will not render the patient ineligible.
boolean
C1514457 (UMLS CUI [1])
patients with brain metastasis, adequately treated
Item
patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for > 3 months.
boolean
C0220650 (UMLS CUI [1,1])
C0332154 (UMLS CUI [1,2])
C0332154 (UMLS CUI [1,2])
received any anti-cancer investigational agent
Item
patients who have received any anti-cancer investigational agent in the month prior to inclusion.
boolean
C0920425 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
previously treated with docetaxel(taxotere)or capecitabine (xeloda)
Item
patients previously treated with docetaxel(taxotere)or capecitabine (xeloda).
boolean
C2114510 (UMLS CUI [1,1])
C0796483 (UMLS CUI [1,2])
C0796483 (UMLS CUI [1,2])
GIT function, dysphagia, malabsorption
Item
patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
boolean
C0516983 (UMLS CUI [1,1])
C0011168 (UMLS CUI [1,2])
C0024523 (UMLS CUI [1,3])
C0011168 (UMLS CUI [1,2])
C0024523 (UMLS CUI [1,3])
renal impairment
Item
patients with renal impairment (creatinine clearance below 30 ml/min calculated according to cockcroft and gault, see appendix d), since capecitabine is contraindicated in patients with severe renal impairment.
boolean
C0151746 (UMLS CUI [1])