ID

19635

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00581256

Stichworte

Versionen (1)
  1. 17.01.17 17.01.17 -
Hochgeladen am

17. Januar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00581256

Englisch

Eligibility Breast Cancer NCT00581256

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
Eligibility Criteria
Beschreibung

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).
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Breast Carcinoma Left sided

Datentyp

boolean

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

Gender

Datentyp

boolean

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

Adult | Age

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

ECOG performance status

Datentyp

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.
Beschreibung

Therapeutic radiology procedure | Therapeutic procedure Radiation Field Lesion of breast

Datentyp

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.
Beschreibung

Awareness disease characteristic Neoplasm

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

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:
Beschreibung

Therapeutic radiology procedure Ability Hematologic Test

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

Exclusion Criteria

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

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
Beschreibung

Impaired mobility | Positioning patient Therapeutic radiology procedure

Datentyp

boolean

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

Medical condition Unstable Clinical

Datentyp

boolean

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

Disease Life Threatening

Datentyp

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.
Beschreibung

Imaging Agents Technetium 99m | Allergic Reaction Life Threatening Serious

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Active Breathing Coordinator-Mediated Radiation Therapy Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3890225
UMLS CUI [1,2]
C1299582
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Ähnliche Modelle

Eligibility Breast Cancer NCT00581256

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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