ID

13309

Beschreibung

Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00724386

Link

https://clinicaltrials.gov/show/NCT00724386

Stichworte

Versionen (1)
  1. 02.02.16 02.02.16 -
Hochgeladen am

2. Februar 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00724386

Englisch

Eligibility Breast Cancer NCT00724386

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:
Beschreibung

Breast Cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0184774
UMLS CUI [4]
C1332928
1. patients with locally advanced unresectable stage iiia or iiib;
Beschreibung

Staging

Datentyp

boolean

Alias
UMLS CUI [1]
C2216698
UMLS CUI [2]
C2216699
2. patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
Beschreibung

Locally recurrent disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0861355
UMLS CUI [1,2]
C1511562
3. patients with metastatic disease and uncontrolled locoregional disease are eligible.
Beschreibung

Staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2]
C1707001
prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
Beschreibung

Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C3540781
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0002475
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1328050
prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
Beschreibung

palliative radiation

Datentyp

boolean

Alias
UMLS CUI [1]
C3641903
4 weeks since any prior treatments (excluding hormonal therapy). concurrent hormonal therapy is not allowed.
Beschreibung

Prior/ concurrent Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0877050
aged 18 years or older
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
calgb performance status of 0 - 2
Beschreibung

calgb performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
life expectance of at least 12 weeks
Beschreibung

Life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
initial laboratory data:
Beschreibung

laboratory data

Datentyp

boolean

Alias
UMLS CUI [1]
C0022885
anc count > 1500/mm3
Beschreibung

anc count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100,000/mm3
Beschreibung

platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
creatine ≤ 2.0 mg/dl
Beschreibung

creatine

Datentyp

boolean

Alias
UMLS CUI [1]
C0201973
bilirubin ≤ 1.5 mg/dl
Beschreibung

bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
alt (sgpt) ≤ 3 times the upper limit of normal
Beschreibung

Liver enzymes

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
signed informed consent
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
Beschreibung

Prior radiation

Datentyp

boolean

Alias
UMLS CUI [1]
C0458344
subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
Beschreibung

Gynaecological status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032976
UMLS CUI [3]
C0700589
patients with a documented hypersensitivity to e.coli derived proteins are excluded.
Beschreibung

Allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014834
UMLS CUI [1,3]
C1441547
UMLS CUI [1,4]
C0033684
no other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Ähnliche Modelle

Eligibility Breast Cancer NCT00724386

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Cancer
Item
histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:
boolean
C0858252 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0184774 (UMLS CUI [3])
C1332928 (UMLS CUI [4])
Staging
Item
1. patients with locally advanced unresectable stage iiia or iiib;
boolean
C2216698 (UMLS CUI [1])
C2216699 (UMLS CUI [2])
Locally recurrent disease
Item
2. patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
boolean
C0861355 (UMLS CUI [1,1])
C1511562 (UMLS CUI [1,2])
Staging
Item
3. patients with metastatic disease and uncontrolled locoregional disease are eligible.
boolean
C0278488 (UMLS CUI [1])
C1707001 (UMLS CUI [2])
Chemotherapy
Item
prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
boolean
C0392920 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3540781 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0002475 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1328050 (UMLS CUI [3,3])
palliative radiation
Item
prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
boolean
C3641903 (UMLS CUI [1])
Prior/ concurrent Therapy
Item
4 weeks since any prior treatments (excluding hormonal therapy). concurrent hormonal therapy is not allowed.
boolean
C0808070 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0877050 (UMLS CUI [2])
age
Item
aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
calgb performance status
Item
calgb performance status of 0 - 2
boolean
C1518965 (UMLS CUI [1])
Life expectancy
Item
life expectance of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
laboratory data
Item
initial laboratory data:
boolean
C0022885 (UMLS CUI [1])
anc count
Item
anc count > 1500/mm3
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count > 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
creatine
Item
creatine ≤ 2.0 mg/dl
boolean
C0201973 (UMLS CUI [1])
bilirubin
Item
bilirubin ≤ 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Liver enzymes
Item
alt (sgpt) ≤ 3 times the upper limit of normal
boolean
C0201836 (UMLS CUI [1])
informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior radiation
Item
prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
boolean
C0458344 (UMLS CUI [1])
Gynaecological status
Item
subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
boolean
C0032961 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Allergy
Item
patients with a documented hypersensitivity to e.coli derived proteins are excluded.
boolean
C0020517 (UMLS CUI [1,1])
C0014834 (UMLS CUI [1,2])
C1441547 (UMLS CUI [1,3])
C0033684 (UMLS CUI [1,4])
Comorbidity
Item
no other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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