ID

35849

Descrição

Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02474641

Link

https://clinicaltrials.gov/show/NCT02474641

Palavras-chave

Versões (1)
  1. 27/03/2019 27/03/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de março de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Early-Stage Breast Carcinoma NCT02474641

Inglês

Eligibility Early-Stage Breast Carcinoma NCT02474641

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, her-2/neu status upa/pai-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
Descrição

Breast Carcinoma | Breast-Conserving Surgery | Negative Surgical Margin | Independent of Risk factors Additional | Lymph node Status Positive | Lymph node Status Negative High risk | Estrogen Receptor Status | Progesterone Receptor Status | HER2/Neu Status | Urokinase Plasminogen Activator Inhibitor 1 Criteria | Systemic therapy Postoperative | Chemotherapy | Hormone Therapy | Antibody therapy | Diphosphonates

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0917927
UMLS CUI [3]
C1709157
UMLS CUI [4,1]
C0332291
UMLS CUI [4,2]
C0035648
UMLS CUI [4,3]
C1524062
UMLS CUI [5,1]
C0024204
UMLS CUI [5,2]
C0449438
UMLS CUI [5,3]
C1514241
UMLS CUI [6,1]
C0024204
UMLS CUI [6,2]
C0449438
UMLS CUI [6,3]
C1513916
UMLS CUI [6,4]
C4319571
UMLS CUI [7,1]
C0034804
UMLS CUI [7,2]
C0449438
UMLS CUI [8]
C1514471
UMLS CUI [9]
C1512413
UMLS CUI [10,1]
C0042071
UMLS CUI [10,2]
C0030190
UMLS CUI [10,3]
C0243161
UMLS CUI [11,1]
C1515119
UMLS CUI [11,2]
C0032790
UMLS CUI [12]
C0392920
UMLS CUI [13]
C0279025
UMLS CUI [14]
C0281176
UMLS CUI [15]
C0012544
indication to adjuvant radiotherapy including boost radiotherapy
Descrição

Indication Adjuvant Radiotherapy | Indication Boost radiation therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0242939
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C2919491
clearly identified primary tumor region preferably by radiopaque clips
Descrição

Primary tumor region Identified | Markers, Radiopaque

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205147
UMLS CUI [1,3]
C0205396
UMLS CUI [2]
C0181739
primary wound healing after breast conserving therapy without signs of infection
Descrição

Wound Healing Post Breast conserving therapy | Signs Absent Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0043240
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0024885
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0009450
age ≥ 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ecog ≤ 2 performance status
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
compliance regarding treatment appointments and toxicity
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
linguistic and cognitive ability to understand the questionnaires
Descrição

Language comprehension Questionnaires | Comprehension Questionnaires

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0034394
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0034394
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients operated by mastectomy
Descrição

Mastectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024881
no indication for boost radiation (e.g. status after iort)
Descrição

Indication Boost radiation therapy | Status post Intraoperative radiation therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2919491
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0338240
double sided breast cancer
Descrição

Bilateral breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0281267
resection margins positive for disease or insufficient identification of the boost volume
Descrição

Surgical margins Positive Disease | Boost Volume Identification Insufficient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0229985
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C2919491
UMLS CUI [2,2]
C0449468
UMLS CUI [2,3]
C0205396
UMLS CUI [2,4]
C0231180
indication for radiotherapy of the regional lymph nodes
Descrição

Indication Therapeutic radiology procedure Regional lymph nodes

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1179441
history of prior breast or thoracic radiotherapy
Descrição

Radiotherapy to breast Previous | Radiotherapy to thorax Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0948310
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C4038705
UMLS CUI [2,2]
C0205156
extended postoperative seroma at the beginning of radiotherapy
Descrição

Postoperative seroma Extended

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1998103
UMLS CUI [1,2]
C0231449
previously administered radiotherapy not allowing the required dose
Descrição

Therapeutic radiology procedure Previous | Dose Required Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0332268
pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
Descrição

Treatment Cancer Other | Study Subject Participation Status | Testing Therapeutic radiology procedure | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1707251
UMLS CUI [2]
C2348568
UMLS CUI [3,1]
C0039593
UMLS CUI [3,2]
C1522449
UMLS CUI [4]
C0013230
patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance
Descrição

Disease Adverse effects Treatment Compliance | Physical illness Serious Uncontrolled | Cerebrovascular Disorders Serious Uncontrolled | Myocardial Infarction | Nervous system disorder | Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0879626
UMLS CUI [1,3]
C4319828
UMLS CUI [2,1]
C0683323
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0007820
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0205318
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0004936
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Similar models

Eligibility Early-Stage Breast Carcinoma NCT02474641

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Breast-Conserving Surgery | Negative Surgical Margin | Independent of Risk factors Additional | Lymph node Status Positive | Lymph node Status Negative High risk | Estrogen Receptor Status | Progesterone Receptor Status | HER2/Neu Status | Urokinase Plasminogen Activator Inhibitor 1 Criteria | Systemic therapy Postoperative | Chemotherapy | Hormone Therapy | Antibody therapy | Diphosphonates
Item
histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, her-2/neu status upa/pai-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
boolean
C0678222 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
C1709157 (UMLS CUI [3])
C0332291 (UMLS CUI [4,1])
C0035648 (UMLS CUI [4,2])
C1524062 (UMLS CUI [4,3])
C0024204 (UMLS CUI [5,1])
C0449438 (UMLS CUI [5,2])
C1514241 (UMLS CUI [5,3])
C0024204 (UMLS CUI [6,1])
C0449438 (UMLS CUI [6,2])
C1513916 (UMLS CUI [6,3])
C4319571 (UMLS CUI [6,4])
C0034804 (UMLS CUI [7,1])
C0449438 (UMLS CUI [7,2])
C1514471 (UMLS CUI [8])
C1512413 (UMLS CUI [9])
C0042071 (UMLS CUI [10,1])
C0030190 (UMLS CUI [10,2])
C0243161 (UMLS CUI [10,3])
C1515119 (UMLS CUI [11,1])
C0032790 (UMLS CUI [11,2])
C0392920 (UMLS CUI [12])
C0279025 (UMLS CUI [13])
C0281176 (UMLS CUI [14])
C0012544 (UMLS CUI [15])
Indication Adjuvant Radiotherapy | Indication Boost radiation therapy
Item
indication to adjuvant radiotherapy including boost radiotherapy
boolean
C3146298 (UMLS CUI [1,1])
C0242939 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C2919491 (UMLS CUI [2,2])
Primary tumor region Identified | Markers, Radiopaque
Item
clearly identified primary tumor region preferably by radiopaque clips
boolean
C0677930 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C0205396 (UMLS CUI [1,3])
C0181739 (UMLS CUI [2])
Wound Healing Post Breast conserving therapy | Signs Absent Communicable Disease
Item
primary wound healing after breast conserving therapy without signs of infection
boolean
C0043240 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0024885 (UMLS CUI [1,3])
C0311392 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog ≤ 2 performance status
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
compliance regarding treatment appointments and toxicity
boolean
C0525058 (UMLS CUI [1])
Language comprehension Questionnaires | Comprehension Questionnaires
Item
linguistic and cognitive ability to understand the questionnaires
boolean
C0233733 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Mastectomy
Item
patients operated by mastectomy
boolean
C0024881 (UMLS CUI [1])
Indication Boost radiation therapy | Status post Intraoperative radiation therapy
Item
no indication for boost radiation (e.g. status after iort)
boolean
C3146298 (UMLS CUI [1,1])
C2919491 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0338240 (UMLS CUI [2,2])
Bilateral breast cancer
Item
double sided breast cancer
boolean
C0281267 (UMLS CUI [1])
Surgical margins Positive Disease | Boost Volume Identification Insufficient
Item
resection margins positive for disease or insufficient identification of the boost volume
boolean
C0229985 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2919491 (UMLS CUI [2,1])
C0449468 (UMLS CUI [2,2])
C0205396 (UMLS CUI [2,3])
C0231180 (UMLS CUI [2,4])
Indication Therapeutic radiology procedure Regional lymph nodes
Item
indication for radiotherapy of the regional lymph nodes
boolean
C3146298 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1179441 (UMLS CUI [1,3])
Radiotherapy to breast Previous | Radiotherapy to thorax Previous
Item
history of prior breast or thoracic radiotherapy
boolean
C0948310 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C4038705 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Postoperative seroma Extended
Item
extended postoperative seroma at the beginning of radiotherapy
boolean
C1998103 (UMLS CUI [1,1])
C0231449 (UMLS CUI [1,2])
Therapeutic radiology procedure Previous | Dose Required Lacking
Item
previously administered radiotherapy not allowing the required dose
boolean
C1522449 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Treatment Cancer Other | Study Subject Participation Status | Testing Therapeutic radiology procedure | Investigational New Drugs
Item
treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
boolean
C0087111 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0039593 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4])
Disease Adverse effects Treatment Compliance | Physical illness Serious Uncontrolled | Cerebrovascular Disorders Serious Uncontrolled | Myocardial Infarction | Nervous system disorder | Mental disorders
Item
patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance
boolean
C0012634 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C0683323 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0007820 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0027051 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
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