ID

19635

Description

A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00581256

Lien

https://clinicaltrials.gov/show/NCT00581256

Mots-clés

Versions (1)
  1. 17/01/2017 17/01/2017 -
Téléchargé le

17 janvier 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00581256

Anglais

Eligibility Breast Cancer NCT00581256

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Eligibility Criteria
Description

Eligibility Criteria

breast cancer diagnosis: patients must have histologically confirmed adenocarcinoma of the breast requiring comprehensive loco-regional irradiation that includes treatment to the intact breast/chest wall, supraclavicular (scv), infraclavicular nodes (icv), and internal mammary nodes (imn).
Description

Breast Carcinoma | Breast adenocarcinoma Requirement Therapeutic radiology procedure Local-Regional Comprehensive | Therapeutic procedure Breast Intact | Therapeutic procedure chest wall Intact | Therapeutic procedure supraclavicular nodes | Therapeutic procedure Infraclavicular nodes | Therapeutic procedure Internal mammary nodes

Type de données

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0858252
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1522449
UMLS CUI [2,4]
C1947913
UMLS CUI [2,5]
C1880156
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0006141
UMLS CUI [3,3]
C0205266
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1279035
UMLS CUI [4,3]
C0205266
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0229730
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0229743
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0542554
patients must have pathologic t 1, 2, 3 or 4, n 1, 2, or 3 stage ii or iii disease as defined by the ajcc staging system, 6th edition. patients who do not undergo axillary staging but are at risk for nodal involvement may also be treated.
Description

Disease TNM clinical staging | Axillary lymph node level | Lymphomatous nodal involvement At risk

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0441924
UMLS CUI [3,1]
C0441949
UMLS CUI [3,2]
C1444641
all patients must have left-sided breast cancer.
Description

Breast Carcinoma Left sided

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0443246
both men and women are eligible.
Description

Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
patients must be adults (18 years of age or older)
Description

Adult | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
for women of child-bearing age, effective contraception must be used. a written statement must be obtained that the patient is not pregnant. if there is any question of pregnancy at time of therapeutic rt or at time of each spect-ct scan, a pregnancy test will be done to confirm the patient is not pregnant.
Description

Childbearing Potential Contraceptive methods | Pregnancy Test | Therapeutic radiology procedure | Single photon emission computed tomography with computed tomography

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0032976
UMLS CUI [3]
C1522449
UMLS CUI [4]
C3472245
performance status should be 0-2 by ecog criteria.
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
patients that have received prior rt may be enrolled on the present study if the new breast lesion can be treated with no overlap of rt fields.
Description

Therapeutic radiology procedure | Therapeutic procedure Radiation Field Lesion of breast

Type de données

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1882536
UMLS CUI [2,3]
C0567489
patients must be aware of the neoplastic nature of her/his disease.
Description

Awareness disease characteristic Neoplasm

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004448
UMLS CUI [1,2]
C0599878
UMLS CUI [1,3]
C0027651
patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with the institutional review board (irb) of the university of michigan and federal guidelines.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
patients' blood tests should indicate they are able to tolerate radiotherapy. tests must be done within 28 days of registration:
Description

Therapeutic radiology procedure Ability Hematologic Test

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0018941
cbc with differential and platelet count (hemoglobin > 8.0 g/dl; wbc > 2000/mm3; absolute neutrophil count > 1000/mm3; platelet count > 75,000/mm3.
Description

complete blood count with differential | Platelet Count measurement | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0545131
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0948762
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are pregnant or are nursing are excluded.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
pathologically node negative breast cancer unless treated with neo-adjuvant chemotherapy.
Description

Node-negative breast cancer | Neoadjuvant Chemotherapy Node-negative breast cancer

Type de données

boolean

Alias
UMLS CUI [1]
C3160889
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C3160889
performance status > 2 by ecog criteria
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
patients who are unable to lie on their back and raise their arm above their head in the treatment planning position for radiotherapy
Description

Impaired mobility | Positioning patient Therapeutic radiology procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0518456
UMLS CUI [2,1]
C1561964
UMLS CUI [2,2]
C1522449
patients with a clinically unstable medical condition
Description

Medical condition Unstable Clinical

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205210
patients with a life-threatening disease state
Description

Disease Life Threatening

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826244
history or suspicion of serious life-threatening allergic reaction to tc-99m imaging agents.
Description

Imaging Agents Technetium 99m | Allergic Reaction Life Threatening Serious

Type de données

boolean

Alias
UMLS CUI [1,1]
C1879410
UMLS CUI [1,2]
C0303611
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C0205404
patients that have had breast-conservation surgery with positive margins or any patient with negative margins with a tumor positive for an extensive intraductal component.
Description

Breast-Conserving Surgery Positive Surgical Margin | Negative Surgical Margin Prominent Intraductal Component Present

Type de données

boolean

Alias
UMLS CUI [1,1]
C0917927
UMLS CUI [1,2]
C1709603
UMLS CUI [2,1]
C1709157
UMLS CUI [2,2]
C1882485
patients that are not able to use the abc device.
Description

Active Breathing Coordinator-Mediated Radiation Therapy Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C3890225
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Breast Cancer NCT00581256

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Breast adenocarcinoma Requirement Therapeutic radiology procedure Local-Regional Comprehensive | Therapeutic procedure Breast Intact | Therapeutic procedure chest wall Intact | Therapeutic procedure supraclavicular nodes | Therapeutic procedure Infraclavicular nodes | Therapeutic procedure Internal mammary nodes
Item
breast cancer diagnosis: patients must have histologically confirmed adenocarcinoma of the breast requiring comprehensive loco-regional irradiation that includes treatment to the intact breast/chest wall, supraclavicular (scv), infraclavicular nodes (icv), and internal mammary nodes (imn).
boolean
C0678222 (UMLS CUI [1])
C0858252 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C1947913 (UMLS CUI [2,4])
C1880156 (UMLS CUI [2,5])
C0087111 (UMLS CUI [3,1])
C0006141 (UMLS CUI [3,2])
C0205266 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1279035 (UMLS CUI [4,2])
C0205266 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C0229730 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0229743 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7,1])
C0542554 (UMLS CUI [7,2])
Disease TNM clinical staging | Axillary lymph node level | Lymphomatous nodal involvement At risk
Item
patients must have pathologic t 1, 2, 3 or 4, n 1, 2, or 3 stage ii or iii disease as defined by the ajcc staging system, 6th edition. patients who do not undergo axillary staging but are at risk for nodal involvement may also be treated.
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0441924 (UMLS CUI [2])
C0441949 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
Breast Carcinoma Left sided
Item
all patients must have left-sided breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
Gender
Item
both men and women are eligible.
boolean
C0079399 (UMLS CUI [1])
Adult | Age
Item
patients must be adults (18 years of age or older)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Pregnancy Test | Therapeutic radiology procedure | Single photon emission computed tomography with computed tomography
Item
for women of child-bearing age, effective contraception must be used. a written statement must be obtained that the patient is not pregnant. if there is any question of pregnancy at time of therapeutic rt or at time of each spect-ct scan, a pregnancy test will be done to confirm the patient is not pregnant.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032976 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C3472245 (UMLS CUI [4])
ECOG performance status
Item
performance status should be 0-2 by ecog criteria.
boolean
C1520224 (UMLS CUI [1])
Therapeutic radiology procedure | Therapeutic procedure Radiation Field Lesion of breast
Item
patients that have received prior rt may be enrolled on the present study if the new breast lesion can be treated with no overlap of rt fields.
boolean
C1522449 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1882536 (UMLS CUI [2,2])
C0567489 (UMLS CUI [2,3])
Awareness disease characteristic Neoplasm
Item
patients must be aware of the neoplastic nature of her/his disease.
boolean
C0004448 (UMLS CUI [1,1])
C0599878 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
Informed Consent
Item
patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with the institutional review board (irb) of the university of michigan and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Therapeutic radiology procedure Ability Hematologic Test
Item
patients' blood tests should indicate they are able to tolerate radiotherapy. tests must be done within 28 days of registration:
boolean
C1522449 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
complete blood count with differential | Platelet Count measurement | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count
Item
cbc with differential and platelet count (hemoglobin > 8.0 g/dl; wbc > 2000/mm3; absolute neutrophil count > 1000/mm3; platelet count > 75,000/mm3.
boolean
C0545131 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
patients who are pregnant or are nursing are excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Node-negative breast cancer | Neoadjuvant Chemotherapy Node-negative breast cancer
Item
pathologically node negative breast cancer unless treated with neo-adjuvant chemotherapy.
boolean
C3160889 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C3160889 (UMLS CUI [2,3])
ECOG performance status
Item
performance status > 2 by ecog criteria
boolean
C1520224 (UMLS CUI [1])
Impaired mobility | Positioning patient Therapeutic radiology procedure
Item
patients who are unable to lie on their back and raise their arm above their head in the treatment planning position for radiotherapy
boolean
C0518456 (UMLS CUI [1])
C1561964 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Medical condition Unstable Clinical
Item
patients with a clinically unstable medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Disease Life Threatening
Item
patients with a life-threatening disease state
boolean
C0012634 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Imaging Agents Technetium 99m | Allergic Reaction Life Threatening Serious
Item
history or suspicion of serious life-threatening allergic reaction to tc-99m imaging agents.
boolean
C1879410 (UMLS CUI [1,1])
C0303611 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Breast-Conserving Surgery Positive Surgical Margin | Negative Surgical Margin Prominent Intraductal Component Present
Item
patients that have had breast-conservation surgery with positive margins or any patient with negative margins with a tumor positive for an extensive intraductal component.
boolean
C0917927 (UMLS CUI [1,1])
C1709603 (UMLS CUI [1,2])
C1709157 (UMLS CUI [2,1])
C1882485 (UMLS CUI [2,2])
Active Breathing Coordinator-Mediated Radiation Therapy Unable
Item
patients that are not able to use the abc device.
boolean
C3890225 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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