ID

24553

Beschreibung

Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35; ODM derived from: https://clinicaltrials.gov/show/NCT00958321

Link

https://clinicaltrials.gov/show/NCT00958321

Stichworte

Versionen (1)
  1. 06.08.17 06.08.17 -
Hochgeladen am

6. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00958321

Englisch

Eligibility Lung Cancer NCT00958321

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven (biopsy or cytology) nsclc (scc, adenocarcinoma, large cell)
Beschreibung

Non-Small Cell Lung Carcinoma | Squamous cell carcinoma of lung | Adenocarcinoma of lung | Large cell carcinoma of lung

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0149782
UMLS CUI [3]
C0152013
UMLS CUI [4]
C0345958
tnm clinical non-operable stage i/ii and non-resectable stage iiia/b without pleural effusion
Beschreibung

TNM clinical staging Inoperable | TNM clinical staging unresectable | Pleural effusion Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0205187
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C0032227
UMLS CUI [3,2]
C0332197
measurable disease
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
no other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
Beschreibung

Malignant Neoplasms | Skin carcinoma | Interval Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3,1]
C1272706
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
patient suitable for radical 3-dcrt
Beschreibung

Patient suitable Conformal Radiotherapy Radical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0600521
UMLS CUI [1,4]
C0439807
ecog-performance status ≤ 2 / kps > or equal to 60
Beschreibung

ECOG performance status | Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
weight loss <10% within the 3 months prior to diagnosis
Beschreibung

Weight decreased Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
no prior radiotherapy to the thorax
Beschreibung

Radiotherapy to thorax Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0332197
patient is suitable for lung-board immobilisation
Beschreibung

Patient suitable Immobilization Lung Board

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0020944
UMLS CUI [1,4]
C0024109
UMLS CUI [1,5]
C0972401
no chemotherapy received prior to planning pet-ct scan
Beschreibung

Chemotherapy Absent | PET/CT scan Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1699633
UMLS CUI [2,2]
C1301732
age 18 and over
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
provision of written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
Beschreibung

Disease Study Subject Participation Status Unfavorable | Laboratory finding Study Subject Participation Status Unfavorable | Disease Protocol Compliance Unlikely | Laboratory finding Protocol Compliance Unlikely

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0750558
UMLS CUI [4,1]
C0587081
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0750558
fev1 < 1
Beschreibung

PULMONARY FUNCTION TEST FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
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Ähnliche Modelle

Eligibility Lung Cancer NCT00958321

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Squamous cell carcinoma of lung | Adenocarcinoma of lung | Large cell carcinoma of lung
Item
histologically proven (biopsy or cytology) nsclc (scc, adenocarcinoma, large cell)
boolean
C0007131 (UMLS CUI [1])
C0149782 (UMLS CUI [2])
C0152013 (UMLS CUI [3])
C0345958 (UMLS CUI [4])
TNM clinical staging Inoperable | TNM clinical staging unresectable | Pleural effusion Absent
Item
tnm clinical non-operable stage i/ii and non-resectable stage iiia/b without pleural effusion
boolean
C3258246 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0032227 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Malignant Neoplasms | Skin carcinoma | Interval Disease Free of
Item
no other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C1272706 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Patient suitable Conformal Radiotherapy Radical
Item
patient suitable for radical 3-dcrt
boolean
C0030705 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0600521 (UMLS CUI [1,3])
C0439807 (UMLS CUI [1,4])
ECOG performance status | Karnofsky Performance Status
Item
ecog-performance status ≤ 2 / kps > or equal to 60
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Weight decreased Percentage
Item
weight loss <10% within the 3 months prior to diagnosis
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Radiotherapy to thorax Absent
Item
no prior radiotherapy to the thorax
boolean
C4038705 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Patient suitable Immobilization Lung Board
Item
patient is suitable for lung-board immobilisation
boolean
C0030705 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0020944 (UMLS CUI [1,3])
C0024109 (UMLS CUI [1,4])
C0972401 (UMLS CUI [1,5])
Chemotherapy Absent | PET/CT scan Planned
Item
no chemotherapy received prior to planning pet-ct scan
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1699633 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Age
Item
age 18 and over
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Study Subject Participation Status Unfavorable | Laboratory finding Study Subject Participation Status Unfavorable | Disease Protocol Compliance Unlikely | Laboratory finding Protocol Compliance Unlikely
Item
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])
C0587081 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0750558 (UMLS CUI [4,3])
PULMONARY FUNCTION TEST FEV1
Item
fev1 < 1
boolean
C0748133 (UMLS CUI [1])
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