ID

13128

Description

Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00983684

Link

https://clinicaltrials.gov/show/NCT00983684

Keywords

Versions (1)
  1. 1/18/16 1/18/16 -
Uploaded on

January 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Invasive Breast Cancer NCT00983684

English

Eligibility Invasive Breast Cancer NCT00983684

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 45 years or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
operable invasive breast cancer (t1 and small t2, n0-1, m0) confirmed by cytological or histological examination
Description

breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0010819
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0019638
UMLS CUI [2,2]
C0678222
suitable for breast conserving surgery
Description

surgery

Data type

boolean

Alias
UMLS CUI [1]
C0038894
previously diagnosed and treated contralateral breast cancer may be entered but will be randomised to a separate stratum.
Description

contralateral breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0441988
available for regular follow-up for at least ten years.
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
note: individual centres may wish to restrict entry to a more exactly defined subset of patients, in which case, only patients with these characteristics may be entered by that particular centre. for example, centres may decide at outset to recruit only women over 50 or even over 65 years of age. such policies must be pre-defined in writing and approved by the international steering committee.
Description

ID.6

Data type

text

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than one obvious cancer in the same breast as diagnosed by clinical examination, mammography or ultrasonography.
Description

multifocal carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205292
bilateral breast cancer at the time of diagnosis.
Description

bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0238767
ipsilateral breast had a previous cancer and/or irradiation.
Description

irradiation previous cancer

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0678222
patients known to have brca2 gene mutations, but testing for gene mutations is not required
Description

brca2

Data type

boolean

Alias
UMLS CUI [1]
C0598034
lobular cancer or extensive intraductal component (eic =>25% of the tumour is intraductal) on core biopsy or initial pathology (if performed)
Description

biopsy, pathology

Data type

boolean

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C0030664
patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumour size should be excluded; those given short duration (up to 4 weeks) systemic therapy can be included.
Description

neoadjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0600558
patients presenting with gross nodal disease, considered to be clinically malignant or proven cytologically or by scanning. in general, 4 or more positive nodes or extranodal spread are not suitable for targit alone and should receive ebrt as well. however, individual centres may decide that anything more than micrometastasis should receive ebrt.
Description

lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C0024204
patients with any severe concomitant disease that may limit their life expectancy.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0023671
previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater.
Description

cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
any factor included as exclusion criterion in the local centre's treatment policy. this is particularly relevant to patients entered into the post pathology stratum.
Description

additional criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
no more than 30 days can have elapsed between last breast cancer surgery (not axillary) and entry into the trial for patients in the post-pathology stratification.
Description

time

Data type

boolean

Alias
UMLS CUI [1]
C0040223
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Similar models

Eligibility Invasive Breast Cancer NCT00983684

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age 45 years or older
boolean
C0001779 (UMLS CUI [1])
breast cancer
Item
operable invasive breast cancer (t1 and small t2, n0-1, m0) confirmed by cytological or histological examination
boolean
C0010819 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0019638 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
surgery
Item
suitable for breast conserving surgery
boolean
C0038894 (UMLS CUI [1])
contralateral breast cancer
Item
previously diagnosed and treated contralateral breast cancer may be entered but will be randomised to a separate stratum.
boolean
C0678222 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
compliance
Item
available for regular follow-up for at least ten years.
boolean
C1321605 (UMLS CUI [1])
ID.6
Item
note: individual centres may wish to restrict entry to a more exactly defined subset of patients, in which case, only patients with these characteristics may be entered by that particular centre. for example, centres may decide at outset to recruit only women over 50 or even over 65 years of age. such policies must be pre-defined in writing and approved by the international steering committee.
text
Item Group
C0680251 (UMLS CUI)
multifocal carcinoma
Item
more than one obvious cancer in the same breast as diagnosed by clinical examination, mammography or ultrasonography.
boolean
C0678222 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
bilateral breast cancer
Item
bilateral breast cancer at the time of diagnosis.
boolean
C0678222 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
irradiation previous cancer
Item
ipsilateral breast had a previous cancer and/or irradiation.
boolean
C1522449 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
brca2
Item
patients known to have brca2 gene mutations, but testing for gene mutations is not required
boolean
C0598034 (UMLS CUI [1])
biopsy, pathology
Item
lobular cancer or extensive intraductal component (eic =>25% of the tumour is intraductal) on core biopsy or initial pathology (if performed)
boolean
C0005558 (UMLS CUI [1])
C0030664 (UMLS CUI [2])
neoadjuvant therapy
Item
patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumour size should be excluded; those given short duration (up to 4 weeks) systemic therapy can be included.
boolean
C0600558 (UMLS CUI [1])
lymph nodes
Item
patients presenting with gross nodal disease, considered to be clinically malignant or proven cytologically or by scanning. in general, 4 or more positive nodes or extranodal spread are not suitable for targit alone and should receive ebrt as well. however, individual centres may decide that anything more than micrometastasis should receive ebrt.
boolean
C0024204 (UMLS CUI [1])
comorbidity
Item
patients with any severe concomitant disease that may limit their life expectancy.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
cancer
Item
previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater.
boolean
C0006826 (UMLS CUI [1])
additional criteria
Item
any factor included as exclusion criterion in the local centre's treatment policy. this is particularly relevant to patients entered into the post pathology stratum.
boolean
C0680251 (UMLS CUI [1])
time
Item
no more than 30 days can have elapsed between last breast cancer surgery (not axillary) and entry into the trial for patients in the post-pathology stratification.
boolean
C0040223 (UMLS CUI [1])
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