ID

35849

Description

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

Keywords

Versions (1)
  1. 3/27/19 3/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Early-Stage Breast Carcinoma NCT02474641

English

Eligibility Early-Stage Breast Carcinoma NCT02474641

1 forms  
Inclusion Criteria
Description

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)
Description

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

Data type

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
Description

Indication Adjuvant Radiotherapy | Indication Boost radiation therapy

Data type

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
Description

Primary tumor region Identified | Markers, Radiopaque

Data type

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
Description

Wound Healing Post Breast conserving therapy | Signs Absent Communicable Disease

Data type

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
Description

Age

Data type

boolean

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

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent
Description

Informed Consent

Data type

boolean

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

Protocol Compliance

Data type

boolean

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

Language comprehension Questionnaires | Comprehension Questionnaires

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients operated by mastectomy
Description

Mastectomy

Data type

boolean

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

Indication Boost radiation therapy | Status post Intraoperative radiation therapy

Data type

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
Description

Bilateral breast cancer

Data type

boolean

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

Surgical margins Positive Disease | Boost Volume Identification Insufficient

Data type

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
Description

Indication Therapeutic radiology procedure Regional lymph nodes

Data type

boolean

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

Radiotherapy to breast Previous | Radiotherapy to thorax Previous

Data type

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
Description

Postoperative seroma Extended

Data type

boolean

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

Therapeutic radiology procedure Previous | Dose Required Lacking

Data type

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
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Data type

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.
Description

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

Data type

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
Description

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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