ID

27434

Beskrivning

Individual Boosting in Non-Small Cell Lung Cancer Using Hypofractionation, Intensity-modulated Radiation Therapy and Respiratory Gating; ODM derived from: https://clinicaltrials.gov/show/NCT00690963

Länk

https://clinicaltrials.gov/show/NCT00690963

Nyckelord

Versioner (1)
  1. 2017-11-14 2017-11-14 -
Rättsinnehavare

See clinicaltrials.gov

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14 november 2017

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00690963

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT00690963

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, undifferentiated large cell carcinoma, non-small cee; not otherwise specified (nos, diagnosis on cytology alone)
Beskrivning

Malignant neoplasm of lung Unresected Biopsy | Malignant neoplasm of lung Unresected Cytology | Squamous cell carcinoma of lung | Adenocarcinoma of lung | Large cell carcinoma of lung | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242379
UMLS CUI [1,2]
C2986425
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C0242379
UMLS CUI [2,2]
C2986425
UMLS CUI [2,3]
C1305671
UMLS CUI [3]
C0149782
UMLS CUI [4]
C0152013
UMLS CUI [5]
C0345958
UMLS CUI [6]
C3846158
patients with ajcc stage ii, iiia or iiib if all detectable tumour can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes
Beskrivning

TNM clinical staging | Radiation Field Therapy Malignant Neoplasms | Radiation Field Therapy Primary tumor | Radiation Field Therapy Regional lymph nodes Involved

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C1882536
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C1882536
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0677930
UMLS CUI [4,1]
C1882536
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C1179441
UMLS CUI [4,4]
C1314939
patient must be deemed to be suitable to undergo definitive chemo-radiotherapy by the treating physician.
Beskrivning

Patient Suitable Chemoradiotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0436307
age > = 18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog/zubrod status 0-1
Beskrivning

ECOG performance status | Zubrod Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C3714786
patients must have measurable disease on ct imaging
Beskrivning

Measurable Disease CT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
satisfactory granulocytes, platelets, bilirubin, ast and calculated creatinine clearance
Beskrivning

Granulocyte count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201899
UMLS CUI [5]
C2711451
dose volume constraints must be met
Beskrivning

Dosage constraint

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0443288
patient must be able to use the breath-held technique
Beskrivning

Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C3846158
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have undergone complete or subtotal tumour resection
Beskrivning

Cancer resection Complete | Cancer resection Subtotal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0741886
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0741886
UMLS CUI [2,2]
C0728939
patients with post-resection intrathoracic tumour recurrence
Beskrivning

Thoracic Neoplasm Recurrence Post Excision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039981
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0728940
patients eligible for definitive surgery
Beskrivning

Eligibility Operative Surgical Procedures Definitive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0443196
evidence of any small cell histology
Beskrivning

Cells Small Histology Evidence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007634
UMLS CUI [1,2]
C0700321
UMLS CUI [1,3]
C0344441
UMLS CUI [1,4]
C3887511
prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
Beskrivning

Cancer Other | Exception Skin carcinoma | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
exudative pleural effusion, or pleural effusions with positive cytology. minimal pleural effusions which are too small to safely tap (i.e. not visible on chest x-ray) are eligible.
Beskrivning

Exudative pleural effusion | Pleural effusion Positive Cytology | Eligibility Pleural effusion Minimal

Datatyp

boolean

Alias
UMLS CUI [1]
C3887491
UMLS CUI [2,1]
C0032227
UMLS CUI [2,2]
C3846509
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0032227
UMLS CUI [3,3]
C0547040
patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure and uncontrolled arrhythmias
Beskrivning

Myocardial Infarction | Heart Disease Symptomatic | Angina Pectoris | Congestive heart failure | Cardiac Arrhythmia Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0018802
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205318
pregnant women are ineligible. patients with childbearing potential must practice appropriate contraception
Beskrivning

Pregnancy | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
patients with fev1 <= 0.8. patients with fev1 >0.8 and <1.0 to be discussed with a respiratory physician
Beskrivning

FEV1

Datatyp

boolean

Alias
UMLS CUI [1]
C0849974
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00690963

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Malignant neoplasm of lung Unresected Biopsy | Malignant neoplasm of lung Unresected Cytology | Squamous cell carcinoma of lung | Adenocarcinoma of lung | Large cell carcinoma of lung | Other Coding
Item
patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, undifferentiated large cell carcinoma, non-small cee; not otherwise specified (nos, diagnosis on cytology alone)
boolean
C0242379 (UMLS CUI [1,1])
C2986425 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0242379 (UMLS CUI [2,1])
C2986425 (UMLS CUI [2,2])
C1305671 (UMLS CUI [2,3])
C0149782 (UMLS CUI [3])
C0152013 (UMLS CUI [4])
C0345958 (UMLS CUI [5])
C3846158 (UMLS CUI [6])
TNM clinical staging | Radiation Field Therapy Malignant Neoplasms | Radiation Field Therapy Primary tumor | Radiation Field Therapy Regional lymph nodes Involved
Item
patients with ajcc stage ii, iiia or iiib if all detectable tumour can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes
boolean
C3258246 (UMLS CUI [1])
C1882536 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C1882536 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0677930 (UMLS CUI [3,3])
C1882536 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C1179441 (UMLS CUI [4,3])
C1314939 (UMLS CUI [4,4])
Patient Suitable Chemoradiotherapy
Item
patient must be deemed to be suitable to undergo definitive chemo-radiotherapy by the treating physician.
boolean
C0030705 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0436307 (UMLS CUI [1,3])
Age
Item
age > = 18
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Zubrod Performance Status
Item
ecog/zubrod status 0-1
boolean
C1520224 (UMLS CUI [1])
C3714786 (UMLS CUI [2])
Measurable Disease CT
Item
patients must have measurable disease on ct imaging
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Granulocyte count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
satisfactory granulocytes, platelets, bilirubin, ast and calculated creatinine clearance
boolean
C0857490 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C2711451 (UMLS CUI [5])
Dosage constraint
Item
dose volume constraints must be met
boolean
C0178602 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Other Coding
Item
patient must be able to use the breath-held technique
boolean
C3846158 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer resection Complete | Cancer resection Subtotal
Item
patients who have undergone complete or subtotal tumour resection
boolean
C0741886 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0741886 (UMLS CUI [2,1])
C0728939 (UMLS CUI [2,2])
Thoracic Neoplasm Recurrence Post Excision
Item
patients with post-resection intrathoracic tumour recurrence
boolean
C0039981 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0728940 (UMLS CUI [1,4])
Eligibility Operative Surgical Procedures Definitive
Item
patients eligible for definitive surgery
boolean
C1548635 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0443196 (UMLS CUI [1,3])
Cells Small Histology Evidence
Item
evidence of any small cell histology
boolean
C0007634 (UMLS CUI [1,1])
C0700321 (UMLS CUI [1,2])
C0344441 (UMLS CUI [1,3])
C3887511 (UMLS CUI [1,4])
Cancer Other | Exception Skin carcinoma | Exception Disease Free of
Item
prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Exudative pleural effusion | Pleural effusion Positive Cytology | Eligibility Pleural effusion Minimal
Item
exudative pleural effusion, or pleural effusions with positive cytology. minimal pleural effusions which are too small to safely tap (i.e. not visible on chest x-ray) are eligible.
boolean
C3887491 (UMLS CUI [1])
C0032227 (UMLS CUI [2,1])
C3846509 (UMLS CUI [2,2])
C1548635 (UMLS CUI [3,1])
C0032227 (UMLS CUI [3,2])
C0547040 (UMLS CUI [3,3])
Myocardial Infarction | Heart Disease Symptomatic | Angina Pectoris | Congestive heart failure | Cardiac Arrhythmia Uncontrolled
Item
patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure and uncontrolled arrhythmias
boolean
C0027051 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Pregnancy | Childbearing Potential Contraceptive methods
Item
pregnant women are ineligible. patients with childbearing potential must practice appropriate contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
FEV1
Item
patients with fev1 <= 0.8. patients with fev1 >0.8 and <1.0 to be discussed with a respiratory physician
boolean
C0849974 (UMLS CUI [1])
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