ID

23639

Description

Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00872625

Link

https://clinicaltrials.gov/show/NCT00872625

Keywords

Versions (1)
  1. 7/10/17 7/10/17 -
Uploaded on

July 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00872625

English

Eligibility Breast Cancer NCT00872625

1 forms  
Criteria
Description

Criteria

histologically confirmed diagnosis of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
unifocal disease
Description

Unifocal Disease

Data type

boolean

Alias
UMLS CUI [1]
C1710542
non-metastatic disease
Description

Non-Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C1334991
not a candidate for breast-conserving surgery
Description

Breast-Conserving Surgery Indication Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0917927
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C2828389
no superficial breast cancer (defined as the distance between tumor and skin ≤ 1 cm)
Description

Breast Carcinoma Superficial Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205124
UMLS CUI [1,3]
C2828389
undergone mri of the breast to define the macroscopic tumor volume
Description

Magnetic resonance imaging of breast | Gross tumor volume Identified

Data type

boolean

Alias
UMLS CUI [1]
C0344104
UMLS CUI [2,1]
C0475645
UMLS CUI [2,2]
C0205396
undergone scanning of the breast to mark the location for radiotherapy
Description

Breast scan | Location Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1543708
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C1522449
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
who performance status 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
not pregnant or nursing
Description

Pregnancy Excluded | Breast Feeding Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C2828389
fertile patients must use effective contraception during and for 6 months after completion of study treatment
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no counter-indications to surgery, standard neoadjuvant chemotherapy, or insertion of an implantable venous device
Description

Medical contraindication Operative Surgical Procedures Excluded | Medical contraindication Chemotherapy Neoadjuvant Excluded | Medical contraindication Insertion of implantable venous access port Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0600558
UMLS CUI [2,4]
C2828389
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0191115
UMLS CUI [3,3]
C2828389
no patient for whom clinical follow up is impossible for psychological, familial, social, or geographical reasons
Description

Patients Clinical Study Follow-up Unavailable Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C0686905
UMLS CUI [1,4]
C2828389
no patients deprived of liberty or under trusteeship
Description

Patients Freedom Deprivation Excluded | Patients Guardianship Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0016694
UMLS CUI [1,3]
C0871712
UMLS CUI [1,4]
C2828389
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0870627
UMLS CUI [2,3]
C2828389
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
no prior ipsilateral breast irradiation
Description

Therapeutic radiology procedure Breast Ipsilateral Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0441989
UMLS CUI [1,4]
C2828389
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Similar models

Eligibility Breast Cancer NCT00872625

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma
Item
histologically confirmed diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Unifocal Disease
Item
unifocal disease
boolean
C1710542 (UMLS CUI [1])
Non-Metastatic Neoplasm
Item
non-metastatic disease
boolean
C1334991 (UMLS CUI [1])
Breast-Conserving Surgery Indication Excluded
Item
not a candidate for breast-conserving surgery
boolean
C0917927 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Breast Carcinoma Superficial Excluded
Item
no superficial breast cancer (defined as the distance between tumor and skin ≤ 1 cm)
boolean
C0678222 (UMLS CUI [1,1])
C0205124 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Magnetic resonance imaging of breast | Gross tumor volume Identified
Item
undergone mri of the breast to define the macroscopic tumor volume
boolean
C0344104 (UMLS CUI [1])
C0475645 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
Breast scan | Location Therapeutic radiology procedure
Item
undergone scanning of the breast to mark the location for radiotherapy
boolean
C1543708 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Pregnancy Excluded | Breast Feeding Excluded
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for 6 months after completion of study treatment
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Medical contraindication Operative Surgical Procedures Excluded | Medical contraindication Chemotherapy Neoadjuvant Excluded | Medical contraindication Insertion of implantable venous access port Excluded
Item
no counter-indications to surgery, standard neoadjuvant chemotherapy, or insertion of an implantable venous device
boolean
C1301624 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
C2828389 (UMLS CUI [2,4])
C1301624 (UMLS CUI [3,1])
C0191115 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
Patients Clinical Study Follow-up Unavailable Excluded
Item
no patient for whom clinical follow up is impossible for psychological, familial, social, or geographical reasons
boolean
C0030705 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0686905 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
Patients Freedom Deprivation Excluded | Patients Guardianship Excluded
Item
no patients deprived of liberty or under trusteeship
boolean
C0030705 (UMLS CUI [1,1])
C0016694 (UMLS CUI [1,2])
C0871712 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C0870627 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Therapeutic radiology procedure Breast Ipsilateral Excluded
Item
no prior ipsilateral breast irradiation
boolean
C1522449 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
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