ID

19125

Beschreibung

Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00159458

Link

https://clinicaltrials.gov/show/NCT00159458

Stichworte

Versionen (1)
  1. 06.12.16 06.12.16 -
Hochgeladen am

6. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Recurrent Breast Cancer NCT00159458

Englisch

Eligibility Recurrent Breast Cancer NCT00159458

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven dx of recurrent or metastatic breast cancer
Beschreibung

Breast cancer recurrent | Breast Carcinoma TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0278493
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C3258246
must have received at least 1 but not more than 3 prior chemotherapy regimens for recurrent or metastatic breast cancer. patients who relapse within 12 months of completing adjuvant chemotherapy can only have had up to 2 prior regimens for metastatic disease. patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease.
Beschreibung

Chemotherapy Regimen Quantity Breast cancer recurrent | Chemotherapy Regimen Quantity Breast Carcinoma TNM clinical staging | Adjuvant Chemotherapy Completed | Recurrent disease | Anthracyclines | taxane

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0278493
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0678222
UMLS CUI [2,4]
C3258246
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C0205197
UMLS CUI [4]
C0277556
UMLS CUI [5]
C0282564
UMLS CUI [6]
C0215136
unidimensionally measurable dz (by recist)
Beschreibung

Measurable Disease Linear

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
at least 18 yrs of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
swog ps 0-2
Beschreibung

SWOG performance status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519429
UMLS CUI [1,2]
C1518965
agc greater than or equal to 1.5; platelets greater than or equal to 100,000; hgb greater than or equal to 8.0
Beschreibung

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
total bilirubin less than or equal to 2 x uln; sgot and/or sgpt and alk phos up to 2.5 x uln
Beschreibung

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
creatinine less than or equal to 2.0
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
fully recovered from acute toxicities secondary to prior tx
Beschreibung

Toxic effect Secondary to Therapeutic procedure | Patient Recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0521108
signed informed consent (including hipaa authorization)
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
peripheral neuropathy grade 0-1
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior tx with gemcitabine or oxaliplatin. prior tx with cisplatin or carboplatin allowed if completed >12 mos prior to enrollment.
Beschreibung

gemcitabine | oxaliplatin | Cisplatin Completed | Carboplatin Completed

Datentyp

boolean

Alias
UMLS CUI [1]
C0045093
UMLS CUI [2]
C0069717
UMLS CUI [3,1]
C0008838
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0079083
UMLS CUI [4,2]
C0205197
underlying medical, psychiatric, or social conditions that would preclude patient from receiving tx
Beschreibung

Condition Excludes Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0087111
peripheral neuropathy greater than or equal to gr 2
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
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Ähnliche Modelle

Eligibility Recurrent Breast Cancer NCT00159458

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast cancer recurrent | Breast Carcinoma TNM clinical staging
Item
histologically proven dx of recurrent or metastatic breast cancer
boolean
C0278493 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Chemotherapy Regimen Quantity Breast cancer recurrent | Chemotherapy Regimen Quantity Breast Carcinoma TNM clinical staging | Adjuvant Chemotherapy Completed | Recurrent disease | Anthracyclines | taxane
Item
must have received at least 1 but not more than 3 prior chemotherapy regimens for recurrent or metastatic breast cancer. patients who relapse within 12 months of completing adjuvant chemotherapy can only have had up to 2 prior regimens for metastatic disease. patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278493 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C0085533 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4])
C0282564 (UMLS CUI [5])
C0215136 (UMLS CUI [6])
Measurable Disease Linear
Item
unidimensionally measurable dz (by recist)
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
Age
Item
at least 18 yrs of age
boolean
C0001779 (UMLS CUI [1])
SWOG performance status
Item
swog ps 0-2
boolean
C1519429 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
agc greater than or equal to 1.5; platelets greater than or equal to 100,000; hgb greater than or equal to 8.0
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
total bilirubin less than or equal to 2 x uln; sgot and/or sgpt and alk phos up to 2.5 x uln
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Creatinine measurement, serum
Item
creatinine less than or equal to 2.0
boolean
C0201976 (UMLS CUI [1])
Toxic effect Secondary to Therapeutic procedure | Patient Recovered
Item
fully recovered from acute toxicities secondary to prior tx
boolean
C0600688 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
Informed Consent
Item
signed informed consent (including hipaa authorization)
boolean
C0021430 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy grade 0-1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
gemcitabine | oxaliplatin | Cisplatin Completed | Carboplatin Completed
Item
prior tx with gemcitabine or oxaliplatin. prior tx with cisplatin or carboplatin allowed if completed >12 mos prior to enrollment.
boolean
C0045093 (UMLS CUI [1])
C0069717 (UMLS CUI [2])
C0008838 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0079083 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Condition Excludes Therapeutic procedure
Item
underlying medical, psychiatric, or social conditions that would preclude patient from receiving tx
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy greater than or equal to gr 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
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