ID

18409

Beschrijving

Chemoradiotherapy in Patients With Localised Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193921

Link

https://clinicaltrials.gov/show/NCT00193921

Trefwoorden

Versies (1)
  1. 03-11-16 03-11-16 -
Geüploaded op

3 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Carcinoma NCT00193921

Engels

Eligibility Non Small Cell Lung Carcinoma NCT00193921

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven non-small cell lung cancer.
Beschrijving

Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
planned high dose palliative radiation therapy for locoregional control. examples include patients with:
Beschrijving

Palliative Radiation Therapy High dose Control Local regional area

Datatype

boolean

Alias
UMLS CUI [1,1]
C3898008
UMLS CUI [1,2]
C0444956
UMLS CUI [1,3]
C0243148
UMLS CUI [1,4]
C0814836
1. stage i - iiib disease with
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
disease technically unsuitable for radical therapy, or · weight loss in excess of 10%, or
Beschrijving

Disease Inappropriate Radical therapy | Excessive weight loss Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0260176
UMLS CUI [2,1]
C0586746
UMLS CUI [2,2]
C0439165
concurrent medical illness
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
2. patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have a fdg-pet only solitary metastasis.
Beschrijving

Thoracic Disease Advanced Locally | Indication Radical therapy | FDG-Positron Emission Tomography | Metastasis Solitary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039978
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0260176
UMLS CUI [3]
C3641247
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0205171
all potential patients, prior to registration, must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists.
Beschrijving

Patient reviewed Oncologist | Patient reviewed Radiation oncologist | Patient reviewed Radiologist

Datatype

boolean

Alias
UMLS CUI [1,1]
C0451610
UMLS CUI [1,2]
C0259990
UMLS CUI [2,1]
C0451610
UMLS CUI [2,2]
C1514693
UMLS CUI [3,1]
C0451610
UMLS CUI [3,2]
C0260194
no prior radiotherapy or chemotherapy for non-small cell lung cancer.
Beschrijving

prior radiation therapy Non-Small Cell Lung Carcinoma | Prior Chemotherapy Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0007131
ecog performance status 0, 1.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate hepatic, bone marrow and renal function.
Beschrijving

Liver function | Bone Marrow function | Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232804
if patient is female of child bearing potential, she must not be pregnant or lactating. males and females of reproductive potential must practise adequate contraception.
Beschrijving

Childbearing Potential | Pregnancy | Breast Feeding | Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0015895
UMLS CUI [4,2]
C0700589
written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient unable to receive all therapy as an outpatient.
Beschrijving

Outpatient Therapeutic procedure Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1299582
significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
Beschrijving

Medical condition Significant At risk Chemotherapy | Medical condition Significant At risk Therapeutic radiology procedure | Medical condition Significant Exacerbation Due to Chemotherapy | Medical condition Significant Exacerbation Due to Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0392920
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C1522449
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0750502
UMLS CUI [3,3]
C0235874
UMLS CUI [3,4]
C0678226
UMLS CUI [3,5]
C0392920
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0750502
UMLS CUI [4,3]
C0235874
UMLS CUI [4,4]
C0678226
UMLS CUI [4,5]
C1522449
history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
Beschrijving

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix | Malignant Neoplasm In complete remission

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0677874
receiving treatment with another investigational agent.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Non Small Cell Lung Carcinoma NCT00193921

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically proven non-small cell lung cancer.
boolean
C0007131 (UMLS CUI [1])
Palliative Radiation Therapy High dose Control Local regional area
Item
planned high dose palliative radiation therapy for locoregional control. examples include patients with:
boolean
C3898008 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,3])
C0814836 (UMLS CUI [1,4])
TNM clinical staging
Item
1. stage i - iiib disease with
boolean
C3258246 (UMLS CUI [1])
Disease Inappropriate Radical therapy | Excessive weight loss Percentage
Item
disease technically unsuitable for radical therapy, or · weight loss in excess of 10%, or
boolean
C0012634 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0260176 (UMLS CUI [1,3])
C0586746 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Comorbidity
Item
concurrent medical illness
boolean
C0009488 (UMLS CUI [1])
Thoracic Disease Advanced Locally | Indication Radical therapy | FDG-Positron Emission Tomography | Metastasis Solitary
Item
2. patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have a fdg-pet only solitary metastasis.
boolean
C0039978 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0260176 (UMLS CUI [2,2])
C3641247 (UMLS CUI [3])
C0027627 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
Patient reviewed Oncologist | Patient reviewed Radiation oncologist | Patient reviewed Radiologist
Item
all potential patients, prior to registration, must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists.
boolean
C0451610 (UMLS CUI [1,1])
C0259990 (UMLS CUI [1,2])
C0451610 (UMLS CUI [2,1])
C1514693 (UMLS CUI [2,2])
C0451610 (UMLS CUI [3,1])
C0260194 (UMLS CUI [3,2])
prior radiation therapy Non-Small Cell Lung Carcinoma | Prior Chemotherapy Non-Small Cell Lung Carcinoma
Item
no prior radiotherapy or chemotherapy for non-small cell lung cancer.
boolean
C0279134 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0, 1.
boolean
C1520224 (UMLS CUI [1])
Liver function | Bone Marrow function | Renal function
Item
adequate hepatic, bone marrow and renal function.
boolean
C0232741 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3])
Childbearing Potential | Pregnancy | Breast Feeding | Fertility Contraceptive methods
Item
if patient is female of child bearing potential, she must not be pregnant or lactating. males and females of reproductive potential must practise adequate contraception.
boolean
C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0015895 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Outpatient Therapeutic procedure Unable
Item
patient unable to receive all therapy as an outpatient.
boolean
C0029921 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Medical condition Significant At risk Chemotherapy | Medical condition Significant At risk Therapeutic radiology procedure | Medical condition Significant Exacerbation Due to Chemotherapy | Medical condition Significant Exacerbation Due to Therapeutic radiology procedure
Item
significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
boolean
C3843040 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0235874 (UMLS CUI [3,3])
C0678226 (UMLS CUI [3,4])
C0392920 (UMLS CUI [3,5])
C3843040 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0235874 (UMLS CUI [4,3])
C0678226 (UMLS CUI [4,4])
C1522449 (UMLS CUI [4,5])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix | Malignant Neoplasm In complete remission
Item
history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C0006826 (UMLS CUI [4,1])
C0677874 (UMLS CUI [4,2])
Investigational New Drugs
Item
receiving treatment with another investigational agent.
boolean
C0013230 (UMLS CUI [1])
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