ID

44650

Description

Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00818051

Link

https://clinicaltrials.gov/show/NCT00818051

Keywords

Versions (2)
  1. 10/20/17 10/20/17 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00818051

English

Eligibility Breast Cancer NCT00818051

1 forms  
Criteria
Description

Criteria

histologically confirmed invasive breast cancer
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
resectable, unilateral disease
Description

Unilateral disease Resectable

Data type

boolean

Alias
UMLS CUI [1,1]
C4035394
UMLS CUI [1,2]
C1514888
t1-3, n0-1, m0 disease
Description

Disease TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
has undergone prior breast conservation surgery with complete microscopic resection and received appropriate systemic therapy for early breast cancer
Description

Breast-Conserving Surgery | Complete excision Microscopic | Systemic therapy Early-Stage Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0917927
UMLS CUI [2,1]
C0015250
UMLS CUI [2,2]
C0205288
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C2986665
requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:
Description

Tumor Bed Radiation Boost Patient need for | Whole Breast Irradiation Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C3640144
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1511253
UMLS CUI [1,4]
C0686904
UMLS CUI [2,1]
C3897169
UMLS CUI [2,2]
C0686904
age 18-49 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
tumor size > 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)
Description

Tumor size Post Operative Surgical Procedure Primary | Diameter Microscopic Maximum Component Invasive

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C0205225
UMLS CUI [2,1]
C1301886
UMLS CUI [2,2]
C0205288
UMLS CUI [2,3]
C0806909
UMLS CUI [2,4]
C1705248
UMLS CUI [2,5]
C0205281
tumor of any size treated by primary medical therapy
Description

First line treatment Neoplasm Size Any

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C1552551
grade iii disease
Description

Disease TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
minimum microscopic margin of noncancerous tissue < 5 mm (excluding deep margin if at deep fascia)
Description

Minimum Surgical margins Microscopic | Tissue Free of Malignant Neoplasms | Exception Surgical deep margin Deep Fascia

Data type

boolean

Alias
UMLS CUI [1,1]
C1524031
UMLS CUI [1,2]
C0229985
UMLS CUI [1,3]
C0205288
UMLS CUI [2,1]
C0040300
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1300626
UMLS CUI [3,3]
C1511746
lymphovascular invasion
Description

Lymphatic Invasion

Data type

boolean

Alias
UMLS CUI [1]
C1708790
axillary node positive
Description

Positive Axillary Lymph Node

Data type

boolean

Alias
UMLS CUI [1]
C0677929
hormone receptor status not specified
Description

Hormone Receptor Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Description

Menopausal Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
no prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
Description

Cancer Other Excluded | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.18

Data type

boolean

no prior mastectomy
Description

Mastectomy Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0024881
UMLS CUI [1,2]
C2828389
no concurrent chemotherapy except primary or sequential chemotherapy
Description

Chemotherapy Excluded | Exception Chemotherapy Primary | Exception Chemotherapy Sequential

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0205225
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C1705294
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Similar models

Eligibility Breast Cancer NCT00818051

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Invasive carcinoma of breast
Item
histologically confirmed invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Unilateral disease Resectable
Item
resectable, unilateral disease
boolean
C4035394 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
Disease TNM Breast tumor staging
Item
t1-3, n0-1, m0 disease
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Breast-Conserving Surgery | Complete excision Microscopic | Systemic therapy Early-Stage Breast Carcinoma
Item
has undergone prior breast conservation surgery with complete microscopic resection and received appropriate systemic therapy for early breast cancer
boolean
C0917927 (UMLS CUI [1])
C0015250 (UMLS CUI [2,1])
C0205288 (UMLS CUI [2,2])
C1515119 (UMLS CUI [3,1])
C2986665 (UMLS CUI [3,2])
Tumor Bed Radiation Boost Patient need for | Whole Breast Irradiation Patient need for
Item
requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:
boolean
C3640144 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1511253 (UMLS CUI [1,3])
C0686904 (UMLS CUI [1,4])
C3897169 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Age
Item
age 18-49 years
boolean
C0001779 (UMLS CUI [1])
Tumor size Post Operative Surgical Procedure Primary | Diameter Microscopic Maximum Component Invasive
Item
tumor size > 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)
boolean
C0475440 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C1301886 (UMLS CUI [2,1])
C0205288 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
C0205281 (UMLS CUI [2,5])
First line treatment Neoplasm Size Any
Item
tumor of any size treated by primary medical therapy
boolean
C1708063 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C1552551 (UMLS CUI [1,4])
Disease TNM Breast tumor staging
Item
grade iii disease
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Minimum Surgical margins Microscopic | Tissue Free of Malignant Neoplasms | Exception Surgical deep margin Deep Fascia
Item
minimum microscopic margin of noncancerous tissue < 5 mm (excluding deep margin if at deep fascia)
boolean
C1524031 (UMLS CUI [1,1])
C0229985 (UMLS CUI [1,2])
C0205288 (UMLS CUI [1,3])
C0040300 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1300626 (UMLS CUI [3,2])
C1511746 (UMLS CUI [3,3])
Lymphatic Invasion
Item
lymphovascular invasion
boolean
C1708790 (UMLS CUI [1])
Positive Axillary Lymph Node
Item
axillary node positive
boolean
C0677929 (UMLS CUI [1])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Cancer Other Excluded | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
no prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.18
Item
see disease characteristics
boolean
Mastectomy Excluded
Item
no prior mastectomy
boolean
C0024881 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Chemotherapy Excluded | Exception Chemotherapy Primary | Exception Chemotherapy Sequential
Item
no concurrent chemotherapy except primary or sequential chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1705294 (UMLS CUI [3,3])
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