ID

42349

Beskrivning

Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck; ODM derived from: https://clinicaltrials.gov/show/NCT01287390

Länk

https://clinicaltrials.gov/show/NCT01287390

Nyckelord

Versioner (1)
  1. 2021-06-22 2021-06-22 -
Rättsinnehavare

University Hospital, Ghent

Uppladdad den

22 juni 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Primary Non-operated Squamous Cell Carcinoma of Oral Cavity NCT01287390

Engelsk

Eligibility Primary Non-operated Squamous Cell Carcinoma of Oral Cavity NCT01287390

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
Beskrivning

Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007137
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C0226896
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C0679557
UMLS CUI [2,3]
C1280659
UMLS CUI [3,1]
C0007137
UMLS CUI [3,2]
C0679557
UMLS CUI [3,3]
C0020629
UMLS CUI [4,1]
C0007137
UMLS CUI [4,2]
C0679557
UMLS CUI [4,3]
C0023078
primary non-resected tumor and/or patients refused surgery
Beskrivning

Primary non-resected tumor | Primary non-resected tumor and patients refused surgery | Patients refused surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1521996
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C1521996
UMLS CUI [2,4]
C0332197
UMLS CUI [2,5]
C0030705
UMLS CUI [2,6]
C0749192
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0749192
stage t1-4, n0-3; for cancer of the glottis t3-4 or t any n1-3
Beskrivning

Tumor stage classified by TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C3258246
decision of curative radiotherapy or radiochemotherapy made by a multidisciplinary group of head and neck tumors at uz gent and uz gasthuisberg leuven
Beskrivning

Decision of curative radiotherapy or radiochemotherapy made by a multidisciplinary group of head and neck tumors at uz gent and uz gasthuisberg leuven

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1276305
UMLS CUI [1,4]
C0018671
UMLS CUI [1,5]
C1319406
UMLS CUI [1,6]
C1301943
UMLS CUI [2,1]
C0679006
UMLS CUI [2,2]
C0436307
UMLS CUI [2,3]
C1276305
UMLS CUI [2,4]
C0018671
UMLS CUI [2,5]
C1319406
UMLS CUI [2,6]
C1301943
karnofsky performance status >= 70 %
Beskrivning

Karnofsky performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
age >= 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
informed consent obtained, signed and dated before specific protocol procedures
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment combined with brachytherapy
Beskrivning

Concomitant brachytherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006098
UMLS CUI [1,2]
C1707479
prior irradiation to the head and neck region
Beskrivning

Prior irradiation to the head and neck region

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3888854
UMLS CUI [1,2]
C1514463
surgery of the primary tumor except lymph node dissection prior to radiotherapy
Beskrivning

Surgery of the primary tumor except lymph node dissection prior to radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0677930
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C0242382
UMLS CUI [1,5]
C0279134
induction chemotherapy
Beskrivning

Induction chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C3179010
history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years
Beskrivning

History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C1518408
UMLS CUI [1,5]
C0007114
UMLS CUI [1,6]
C1273390
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0332300
UMLS CUI [2,4]
C0851140
UMLS CUI [2,5]
C1273390
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C0332300
UMLS CUI [3,4]
C0006826
UMLS CUI [3,5]
C0677874
distant metastases
Beskrivning

Distant metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C3258247
creatinine clearance (cockroft-gault) =< 60 milliliter/minute before treatment or creatinine value > 1,3 milligram/deciliter
Beskrivning

Abnormal renal function according to creatinine clearance (cockroft-gault) | Abnormal renal function according to creatinine measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2711451
UMLS CUI [1,2]
C0151746
UMLS CUI [2,1]
C0201975
UMLS CUI [2,2]
C0151746
known allergy to the ct-contrast agents
Beskrivning

Known allergy to the ct-contrast agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0009924
UMLS CUI [1,3]
C0040405
pregnant or lactating women
Beskrivning

Pregnancy | breast-feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
Beskrivning

Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [1,4]
C0332307
UMLS CUI [1,5]
C1710028
UMLS CUI [1,6]
C0686907
UMLS CUI [1,7]
C0008976
patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study
Beskrivning

Patient unlikely to comply with protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
UMLS CUI [1,3]
C2188045
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Similar models

Eligibility Primary Non-operated Squamous Cell Carcinoma of Oral Cavity NCT01287390

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
Item
histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
boolean
C0007137 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C0226896 (UMLS CUI [1,3])
C0007137 (UMLS CUI [2,1])
C0679557 (UMLS CUI [2,2])
C1280659 (UMLS CUI [2,3])
C0007137 (UMLS CUI [3,1])
C0679557 (UMLS CUI [3,2])
C0020629 (UMLS CUI [3,3])
C0007137 (UMLS CUI [4,1])
C0679557 (UMLS CUI [4,2])
C0023078 (UMLS CUI [4,3])
Primary non-resected tumor | Primary non-resected tumor and patients refused surgery | Patients refused surgery
Item
primary non-resected tumor and/or patients refused surgery
boolean
C0006826 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1521996 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0006826 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C1521996 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0030705 (UMLS CUI [2,5])
C0749192 (UMLS CUI [2,6])
C0030705 (UMLS CUI [3,1])
C0749192 (UMLS CUI [3,2])
Tumor stage classified by TNM clinical staging
Item
stage t1-4, n0-3; for cancer of the glottis t3-4 or t any n1-3
boolean
C1300072 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Decision of curative radiotherapy or radiochemotherapy made by a multidisciplinary group of head and neck tumors at uz gent and uz gasthuisberg leuven
Item
decision of curative radiotherapy or radiochemotherapy made by a multidisciplinary group of head and neck tumors at uz gent and uz gasthuisberg leuven
boolean
C0679006 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
C0018671 (UMLS CUI [1,4])
C1319406 (UMLS CUI [1,5])
C1301943 (UMLS CUI [1,6])
C0679006 (UMLS CUI [2,1])
C0436307 (UMLS CUI [2,2])
C1276305 (UMLS CUI [2,3])
C0018671 (UMLS CUI [2,4])
C1319406 (UMLS CUI [2,5])
C1301943 (UMLS CUI [2,6])
Karnofsky performance status
Item
karnofsky performance status >= 70 %
boolean
C0206065 (UMLS CUI [1])
Age
Item
age >= 18 years old
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
informed consent obtained, signed and dated before specific protocol procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Concomitant brachytherapy
Item
treatment combined with brachytherapy
boolean
C0006098 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
Prior irradiation to the head and neck region
Item
prior irradiation to the head and neck region
boolean
C3888854 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Surgery of the primary tumor except lymph node dissection prior to radiotherapy
Item
surgery of the primary tumor except lymph node dissection prior to radiotherapy
boolean
C0543467 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0242382 (UMLS CUI [1,4])
C0279134 (UMLS CUI [1,5])
Induction chemotherapy
Item
induction chemotherapy
boolean
C3179010 (UMLS CUI [1])
History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated
Item
history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C1518408 (UMLS CUI [1,4])
C0007114 (UMLS CUI [1,5])
C1273390 (UMLS CUI [1,6])
C0262926 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0332300 (UMLS CUI [2,3])
C0851140 (UMLS CUI [2,4])
C1273390 (UMLS CUI [2,5])
C0262926 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0332300 (UMLS CUI [3,3])
C0006826 (UMLS CUI [3,4])
C0677874 (UMLS CUI [3,5])
Distant metastases
Item
distant metastases
boolean
C3258247 (UMLS CUI [1])
Abnormal renal function according to creatinine clearance (cockroft-gault) | Abnormal renal function according to creatinine measurement
Item
creatinine clearance (cockroft-gault) =< 60 milliliter/minute before treatment or creatinine value > 1,3 milligram/deciliter
boolean
C2711451 (UMLS CUI [1,1])
C0151746 (UMLS CUI [1,2])
C0201975 (UMLS CUI [2,1])
C0151746 (UMLS CUI [2,2])
Known allergy to the ct-contrast agents
Item
known allergy to the ct-contrast agents
boolean
C0020517 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Pregnancy | breast-feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
Item
mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
boolean
C3840291 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
C1710028 (UMLS CUI [1,5])
C0686907 (UMLS CUI [1,6])
C0008976 (UMLS CUI [1,7])
Patient unlikely to comply with protocol
Item
patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C2188045 (UMLS CUI [1,3])
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