ID

40429

Beschreibung

Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.; ODM derived from: https://clinicaltrials.gov/show/NCT01933568

Link

https://clinicaltrials.gov/show/NCT01933568

Stichworte

Versionen (1)
  1. 20.04.20 20.04.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. April 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Inoperable Locally Advanced Non Small Cell Lung Cancer NCT01933568

Englisch

Eligibility Inoperable Locally Advanced Non Small Cell Lung Cancer NCT01933568

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
cytological or histological proven nsclc stage iii or inoperable stage ii, ct1-2a-3n1-3m0 with peripheral tumors < 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is < 5 cm).
Beschreibung

NSCLC TNM clinical staging | NSCLC Inoperable TNM clinical staging | Neoplasms Peripheral Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205187
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0205100
UMLS CUI [3,3]
C1301886
weight loss < 10% in the last three months
Beschreibung

Weight loss Percentage Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
who-performance status ≤ 2
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
Beschreibung

Chemoradiotherapy | Exception Adriamycin | Exception Gemcitabine

Datentyp

boolean

Alias
UMLS CUI [1]
C0436307
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0085752
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0045093
fev1 and dlco > 40 % of the age-adjusted normal value
Beschreibung

FEV1 adjusted for age | DLCO adjusted for age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0849974
UMLS CUI [1,2]
C4300468
UMLS CUI [2,1]
C1516251
UMLS CUI [2,2]
C4300468
minimum required laboratory data bone marrow reserve and hepatic- and renal function
Beschreibung

Bone Marrow Mature Neutrophils Present Minimum | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [1,3]
C1524031
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Beschreibung

Absence Factor Interferes with Protocol Compliance | Absence Factor Interferes with Follow-up | Absence Mental condition | Absence Condition Familial | Absence Sociological Factors | Absence Geographic Factors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1521761
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1521761
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C3274571
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C3840291
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0348080
UMLS CUI [4,3]
C0241888
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C3850138
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0017444
before patient registration, written informed consent must be given according to gcp and national regulations
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with central tumors < 2 cm of the proximal bronchial tree (figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
Beschreibung

Neoplasms Bronchial tree Proximal | Neoplasms Adjacent Mediastinal pleura | Neoplasms Adjacent Pericardial pleura

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0819141
UMLS CUI [1,3]
C0205107
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0205117
UMLS CUI [2,3]
C0225789
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0205117
UMLS CUI [3,3]
C0225793
patients that receive sequential chemoradiotherapy or radiotherapy only.
Beschreibung

Chemoradiotherapy Sequential only | Therapeutic radiology procedure Sequential only

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0436307
UMLS CUI [1,2]
C1705294
UMLS CUI [1,3]
C0205171
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1705294
UMLS CUI [2,3]
C0205171
patients with grade 3 dyspnea at baseline (according to ctcae version 4.03)
Beschreibung

Dyspnea CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C1516728
patients with pancoast tumors
Beschreibung

Pancoast Tumor

Datentyp

boolean

Alias
UMLS CUI [1]
C0549471
prior radiotherapy treatment to the thorax
Beschreibung

Radiotherapy to thorax Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0205156
any contraindications to the administration of thoracic radiotherapy
Beschreibung

Medical contraindication Radiotherapy to thorax

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4038705
pregnant women
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Inoperable Locally Advanced Non Small Cell Lung Cancer NCT01933568

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
NSCLC TNM clinical staging | NSCLC Inoperable TNM clinical staging | Neoplasms Peripheral Diameter
Item
cytological or histological proven nsclc stage iii or inoperable stage ii, ct1-2a-3n1-3m0 with peripheral tumors < 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is < 5 cm).
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C0205100 (UMLS CUI [3,2])
C1301886 (UMLS CUI [3,3])
Weight loss Percentage Timespan
Item
weight loss < 10% in the last three months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
WHO performance status scale
Item
who-performance status ≤ 2
boolean
C1298650 (UMLS CUI [1])
Chemoradiotherapy | Exception Adriamycin | Exception Gemcitabine
Item
patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
boolean
C0436307 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0085752 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0045093 (UMLS CUI [3,2])
FEV1 adjusted for age | DLCO adjusted for age
Item
fev1 and dlco > 40 % of the age-adjusted normal value
boolean
C0849974 (UMLS CUI [1,1])
C4300468 (UMLS CUI [1,2])
C1516251 (UMLS CUI [2,1])
C4300468 (UMLS CUI [2,2])
Bone Marrow Mature Neutrophils Present Minimum | Liver function | Renal function
Item
minimum required laboratory data bone marrow reserve and hepatic- and renal function
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Absence Factor Interferes with Protocol Compliance | Absence Factor Interferes with Follow-up | Absence Mental condition | Absence Condition Familial | Absence Sociological Factors | Absence Geographic Factors
Item
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C0332197 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C1521761 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C3274571 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C3840291 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0348080 (UMLS CUI [4,2])
C0241888 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C3850138 (UMLS CUI [5,2])
C0332197 (UMLS CUI [6,1])
C0017444 (UMLS CUI [6,2])
Informed Consent
Item
before patient registration, written informed consent must be given according to gcp and national regulations
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasms Bronchial tree Proximal | Neoplasms Adjacent Mediastinal pleura | Neoplasms Adjacent Pericardial pleura
Item
patients with central tumors < 2 cm of the proximal bronchial tree (figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
boolean
C0027651 (UMLS CUI [1,1])
C0819141 (UMLS CUI [1,2])
C0205107 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0205117 (UMLS CUI [2,2])
C0225789 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C0205117 (UMLS CUI [3,2])
C0225793 (UMLS CUI [3,3])
Chemoradiotherapy Sequential only | Therapeutic radiology procedure Sequential only
Item
patients that receive sequential chemoradiotherapy or radiotherapy only.
boolean
C0436307 (UMLS CUI [1,1])
C1705294 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C1705294 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Dyspnea CTCAE Grades
Item
patients with grade 3 dyspnea at baseline (according to ctcae version 4.03)
boolean
C0013404 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Pancoast Tumor
Item
patients with pancoast tumors
boolean
C0549471 (UMLS CUI [1])
Radiotherapy to thorax Previous
Item
prior radiotherapy treatment to the thorax
boolean
C4038705 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Medical contraindication Radiotherapy to thorax
Item
any contraindications to the administration of thoracic radiotherapy
boolean
C1301624 (UMLS CUI [1,1])
C4038705 (UMLS CUI [1,2])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video