ID

40429

Description

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

Keywords

Versions (1)
  1. 4/20/20 4/20/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 20, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Inoperable Locally Advanced Non Small Cell Lung Cancer NCT01933568

English

Eligibility Inoperable Locally Advanced Non Small Cell Lung Cancer NCT01933568

1 forms  
Inclusion Criteria
Description

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).
Description

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

Data type

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
Description

Weight loss Percentage Timespan

Data type

boolean

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

WHO performance status scale

Data type

boolean

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

Chemoradiotherapy | Exception Adriamycin | Exception Gemcitabine

Data type

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
Description

FEV1 adjusted for age | DLCO adjusted for age

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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.
Description

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

Data type

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.
Description

Chemoradiotherapy Sequential only | Therapeutic radiology procedure Sequential only

Data type

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)
Description

Dyspnea CTCAE Grades

Data type

boolean

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

Pancoast Tumor

Data type

boolean

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

Radiotherapy to thorax Previous

Data type

boolean

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

Medical contraindication Radiotherapy to thorax

Data type

boolean

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

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Back to the top of the page

Similar models

Eligibility Inoperable Locally Advanced Non Small Cell Lung Cancer NCT01933568

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial