ID

36845

Description

Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01948726 Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies. Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.

Link

https://clinicaltrials.gov/show/NCT01948726

Keywords

Versions (1)
  1. 6/15/19 6/15/19 -
Copyright Holder

University of Schleswig-Holstein

Uploaded on

June 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Hypofractionation for Breast Cancer NCT01948726

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant have histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins?
Description

Histopathiologically cleared breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C4086448
UMLS CUI [1,2]
C0521091
UMLS CUI [1,3]
C0006142
UMLS CUI [1,4]
C0917927
UMLS CUI [1,5]
C1709157
Does the participant have indication to adjuvant radiotherapy including boost radiotherapy?
Description

Radiotherapy indication

Data type

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0242939
UMLS CUI [1,3]
C2919491
Does the participant have a clearly identified primary tumor region preferably by radiopaque clips?
Description

Clearly identified tumor region

Data type

boolean

Alias
UMLS CUI [1,1]
C2963144
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C0677930
UMLS CUI [1,4]
C0181739
UMLS CUI [1,5]
C0175722
Does the participant have primary wound healing after breast conserving therapy without signs of infection?
Description

Primary wound healing without infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0043240
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0917927
UMLS CUI [1,5]
C0332288
UMLS CUI [1,6]
C0513965
Does the subject have pre- and/or postoperative chemotherapy and endocrine therapy permitted when indicated?
Description

Permission of endocrine and chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0032790
UMLS CUI [1,4]
C0445204
UMLS CUI [1,5]
C0521104
UMLS CUI [1,6]
C3146298
Does the participant give written informed consent?
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Was/is the participant operated by mastectomy
Description

Mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C0024881
Does the participant have no indication for boost radiation?
Description

No Boost radiation indication

Data type

boolean

Alias
UMLS CUI [1,1]
C0521090
UMLS CUI [1,2]
C2919491
Does the participant have resection margins positive for disease or insufficient identification of the boost volume?
Description

Positive resection margins or insufficient boost volume identification

Data type

boolean

Alias
UMLS CUI [1]
C1709603
UMLS CUI [2,1]
C0231180
UMLS CUI [2,2]
C0205396
UMLS CUI [2,3]
C2919491
UMLS CUI [2,4]
C0449468
Does the participant have indication for radiotherapy of the regional lymph nodes?
Description

Regional lymph node radiotherapy indication

Data type

boolean

Alias
UMLS CUI [1,1]
C0729852
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1522449
Does the participant have a history of prior breast or thoracic radiotherapy?
Description

History of breast or thorax radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0948310
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C4038705
Does the participant have extended postoperative seroma at the beginning of radiotherapy?
Description

Extended postoperative seroma

Data type

boolean

Alias
UMLS CUI [1,1]
C0231449
UMLS CUI [1,2]
C1998103
UMLS CUI [1,3]
C0439659
UMLS CUI [1,4]
C1522449
Does the participant have psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance?
Description

Mental disorder affecting compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C4319828
UMLS CUI [2,1]
C0848775
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C4319828
Is the participant pregnant, lactating or a woman of child bearing potential, who lacked effective contraception?
Description

Pregnancy, Lactation or Childbearing potential

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2828358
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0332268
UMLS CUI [3,3]
C0700589
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Histopathiologically cleared breast cancer
Item
Does the participant have histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins?
boolean
C4086448 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,3])
C0917927 (UMLS CUI [1,4])
C1709157 (UMLS CUI [1,5])
Radiotherapy indication
Item
Does the participant have indication to adjuvant radiotherapy including boost radiotherapy?
boolean
C0392360 (UMLS CUI [1,1])
C0242939 (UMLS CUI [1,2])
C2919491 (UMLS CUI [1,3])
Clearly identified tumor region
Item
Does the participant have a clearly identified primary tumor region preferably by radiopaque clips?
boolean
C2963144 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C0181739 (UMLS CUI [1,4])
C0175722 (UMLS CUI [1,5])
Primary wound healing without infection
Item
Does the participant have primary wound healing after breast conserving therapy without signs of infection?
boolean
C0043240 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0917927 (UMLS CUI [1,4])
C0332288 (UMLS CUI [1,5])
C0513965 (UMLS CUI [1,6])
Permission of endocrine and chemotherapy
Item
Does the subject have pre- and/or postoperative chemotherapy and endocrine therapy permitted when indicated?
boolean
C3665472 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
C0445204 (UMLS CUI [1,4])
C0521104 (UMLS CUI [1,5])
C3146298 (UMLS CUI [1,6])
Informed consent
Item
Does the participant give written informed consent?
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mastectomy
Item
Was/is the participant operated by mastectomy
boolean
C0024881 (UMLS CUI [1])
No Boost radiation indication
Item
Does the participant have no indication for boost radiation?
boolean
C0521090 (UMLS CUI [1,1])
C2919491 (UMLS CUI [1,2])
Positive resection margins or insufficient boost volume identification
Item
Does the participant have resection margins positive for disease or insufficient identification of the boost volume?
boolean
C1709603 (UMLS CUI [1])
C0231180 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C2919491 (UMLS CUI [2,3])
C0449468 (UMLS CUI [2,4])
Regional lymph node radiotherapy indication
Item
Does the participant have indication for radiotherapy of the regional lymph nodes?
boolean
C0729852 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
History of breast or thorax radiotherapy
Item
Does the participant have a history of prior breast or thoracic radiotherapy?
boolean
C0241889 (UMLS CUI [1,1])
C0948310 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C4038705 (UMLS CUI [2,2])
Extended postoperative seroma
Item
Does the participant have extended postoperative seroma at the beginning of radiotherapy?
boolean
C0231449 (UMLS CUI [1,1])
C1998103 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
Mental disorder affecting compliance
Item
Does the participant have psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance?
boolean
C0004936 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C0848775 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C4319828 (UMLS CUI [2,3])
Pregnancy, Lactation or Childbearing potential
Item
Is the participant pregnant, lactating or a woman of child bearing potential, who lacked effective contraception?
boolean
C0032961 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
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