ID

16284

Beschrijving

Study in Elderly Patients With Early Breast Cancer (ICE); ODM derived from: https://clinicaltrials.gov/show/NCT00196859

Link

https://clinicaltrials.gov/show/NCT00196859

Trefwoorden

Versies (1)
  1. 09-07-16 09-07-16 -
Geüploaded op

9 juli 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00196859

Engels

Eligibility Breast Cancer NCT00196859

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
Beschrijving

written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. histologically confirmed unilateral or bilateral primary carcinoma of the breast.
Beschrijving

primary carcinoma of the breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C1335475
UMLS CUI [1,2]
C0006142
3. age at diagnosis ≥ 65 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
4. adequately surgical treatment with complete resection (ro) of the tumor and > or = 10 axillary nodes. sole sentinel node biopsy is allowed if the sentinel node shows no tumor involvement.
Beschrijving

Surgery outcome

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184788
UMLS CUI [1,2]
C3714726
5. node positive disease irrespective of additional risk factors or node negative disease with at least one other risk factor (histologic tumor size > or = 2 cm, grade ii or iii, er and pr negative)
Beschrijving

Node positive or negative disease

Datatype

boolean

Alias
UMLS CUI [1]
C3160887
UMLS CUI [2]
C3160889
6. no evidence for distant metastasis after complete diagnostic work up
Beschrijving

distant metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C1302548
7. performance status ecog < or = 2
Beschrijving

performance status ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
8. charlson scale of < or = 2
Beschrijving

Charlson scale

Datatype

boolean

Alias
UMLS CUI [1]
C1516737
9. estimated life expectancy of at least 5 years (irrespective of breast cancer diagnosis)
Beschrijving

estimated life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
10. the patient must be accessible for treatment and follow-up.
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1,1]
C0814423
UMLS CUI [1,2]
C0030705
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
Beschrijving

drug hypersensitivity or dihydropyrimidine dehydrogenase deficiency

Datatype

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C1959620
2. inadequate organ function including: leucocytes < 3,5 g/l, platelets < 100 g/l , bilirubin 1.25 times above normal limits, creatinine clearance calculated by the cockroft-gold formula of above 50 ml/min, uncompensated cardiac function, severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
Beschrijving

inadequate organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0679384
3. another primary malignancy with an event-free survival of < 5 years, except curatively treated basalioma of the skin
Beschrijving

another primary malignancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0751623
4. time since axillary dissection > 3 months
Beschrijving

time since axillary dissection

Datatype

boolean

Alias
UMLS CUI [1,1]
C1948053
UMLS CUI [1,2]
C0193867
5. locally advanced, non-operable breast cancer
Beschrijving

locally advanced, non-operable breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0205187
6. previous invasive breast carcinoma
Beschrijving

previous invasive breast carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
7. previous treatment with cytotoxic agents for any reason
Beschrijving

previous treatment with cytotoxic agents

Datatype

boolean

Alias
UMLS CUI [1]
C0304497
8. concurrent treatment with hormonal replacement therapy (treatment should be stopped before entering the trial).
Beschrijving

hormonal replacement therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0282402
9. previous treatment with bisphosphonates for osteoporosis is allowed, however this treatment has to be substituted by the trial medication
Beschrijving

previous treatment with bisphosphonates

Datatype

boolean

Alias
UMLS CUI [1]
C3541401
10. concurrent specific systemic anti-tumor treatment or treatment with experimental compounds within the last 6 months
Beschrijving

Previous chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C3665472
11. concurrent treatment with other tumor specific experimental drugs. participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
Beschrijving

ID.21

Datatype

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C2348568
12. concurrent treatment with virostatic agents like brivudine or analoga sorivudine, concurrent treatment with aminoglycosides
Beschrijving

Virustatic agents or aminoglycosides

Datatype

boolean

Alias
UMLS CUI [1]
C0003451
UMLS CUI [2]
C0002556
13. male patients
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
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Similar models

Eligibility Breast Cancer NCT00196859

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
written informed consent
Item
1. written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
boolean
C0021430 (UMLS CUI [1])
primary carcinoma of the breast
Item
2. histologically confirmed unilateral or bilateral primary carcinoma of the breast.
boolean
C1335475 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
Age
Item
3. age at diagnosis ≥ 65 years
boolean
C0001779 (UMLS CUI [1])
Surgery outcome
Item
4. adequately surgical treatment with complete resection (ro) of the tumor and > or = 10 axillary nodes. sole sentinel node biopsy is allowed if the sentinel node shows no tumor involvement.
boolean
C0184788 (UMLS CUI [1,1])
C3714726 (UMLS CUI [1,2])
Node positive or negative disease
Item
5. node positive disease irrespective of additional risk factors or node negative disease with at least one other risk factor (histologic tumor size > or = 2 cm, grade ii or iii, er and pr negative)
boolean
C3160887 (UMLS CUI [1])
C3160889 (UMLS CUI [2])
distant metastasis
Item
6. no evidence for distant metastasis after complete diagnostic work up
boolean
C1302548 (UMLS CUI [1])
performance status ecog
Item
7. performance status ecog < or = 2
boolean
C1520224 (UMLS CUI [1])
Charlson scale
Item
8. charlson scale of < or = 2
boolean
C1516737 (UMLS CUI [1])
estimated life expectancy
Item
9. estimated life expectancy of at least 5 years (irrespective of breast cancer diagnosis)
boolean
C0023671 (UMLS CUI [1])
ID.10
Item
10. the patient must be accessible for treatment and follow-up.
boolean
C0814423 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
drug hypersensitivity or dihydropyrimidine dehydrogenase deficiency
Item
1. known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
boolean
C0020517 (UMLS CUI [1])
C1959620 (UMLS CUI [2])
inadequate organ function
Item
2. inadequate organ function including: leucocytes < 3,5 g/l, platelets < 100 g/l , bilirubin 1.25 times above normal limits, creatinine clearance calculated by the cockroft-gold formula of above 50 ml/min, uncompensated cardiac function, severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
boolean
C0679384 (UMLS CUI [1])
another primary malignancy
Item
3. another primary malignancy with an event-free survival of < 5 years, except curatively treated basalioma of the skin
boolean
C0009488 (UMLS CUI [1,1])
C0751623 (UMLS CUI [1,2])
time since axillary dissection
Item
4. time since axillary dissection > 3 months
boolean
C1948053 (UMLS CUI [1,1])
C0193867 (UMLS CUI [1,2])
locally advanced, non-operable breast cancer
Item
5. locally advanced, non-operable breast cancer
boolean
C3495949 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
previous invasive breast carcinoma
Item
6. previous invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
previous treatment with cytotoxic agents
Item
7. previous treatment with cytotoxic agents for any reason
boolean
C0304497 (UMLS CUI [1])
hormonal replacement therapy
Item
8. concurrent treatment with hormonal replacement therapy (treatment should be stopped before entering the trial).
boolean
C0282402 (UMLS CUI [1])
previous treatment with bisphosphonates
Item
9. previous treatment with bisphosphonates for osteoporosis is allowed, however this treatment has to be substituted by the trial medication
boolean
C3541401 (UMLS CUI [1])
Previous chemotherapy
Item
10. concurrent specific systemic anti-tumor treatment or treatment with experimental compounds within the last 6 months
boolean
C3665472 (UMLS CUI [1])
ID.21
Item
11. concurrent treatment with other tumor specific experimental drugs. participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
boolean
C0304229 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Virustatic agents or aminoglycosides
Item
12. concurrent treatment with virostatic agents like brivudine or analoga sorivudine, concurrent treatment with aminoglycosides
boolean
C0003451 (UMLS CUI [1])
C0002556 (UMLS CUI [2])
Gender
Item
13. male patients
boolean
C0079399 (UMLS CUI [1])
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