ID

18541

Beschreibung

Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer (PET START Trial); ODM derived from: https://clinicaltrials.gov/show/NCT00136864

Link

https://clinicaltrials.gov/show/NCT00136864

Stichworte

Versionen (2)
  1. 10.11.16 10.11.16 -
  2. 10.11.16 10.11.16 -
Hochgeladen am

10. November 2016

DOI

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Eligibility Non-Small-Cell Lung Carcinoma NCT00136864

Englisch

Eligibility Non-Small-Cell Lung Carcinoma NCT00136864

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological evidence of nsclc. must have documented pathology report with histology indicated (e.g. squamous, adenocarcinoma, large cell, nsclc not otherwise specified).
Beschreibung

Non-Small Cell Lung Carcinoma Evidence of | Squamous cell carcinoma | Adenocarcinoma | Carcinoma, Large Cell | Non-Small Cell Lung Carcinoma NOS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0007137
UMLS CUI [3]
C0001418
UMLS CUI [4]
C0206704
UMLS CUI [5]
C0007131
stage iii (mediastinal node positive) nsclc based on conventional staging (e.g. computed tomography [ct] scan of chest and upper abdomen, ct or magnetic resonance imaging [mri] of brain, bone scan).
Beschreibung

Non-Small Cell Lung Carcinoma | TNM clinical staging | Mediastinal lymph node Positive | Chest CT | CT of upper abdomen | CAT scan of brain | MRI brain procedure | Radioisotope scan of bone

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
UMLS CUI [3,1]
C1279049
UMLS CUI [3,2]
C1514241
UMLS CUI [4]
C0202823
UMLS CUI [5]
C1627748
UMLS CUI [6]
C0412585
UMLS CUI [7]
C0412675
UMLS CUI [8]
C0203668
suitable for combined modality (chemotherapy and radiation) therapy or radical radiation therapy or trimodality therapy (chemotherapy, radiation and surgery).
Beschreibung

Indication Combined Modality Therapy | Indication Therapeutic radiology procedure Radical | Indication Chemotherapy | Indication Therapeutic radiology procedure | Indication Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0009429
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0439807
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0392920
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C1522449
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0543467
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
stage iv nsclc (by conventional staging).
Beschreibung

Non-Small Cell Lung Carcinoma | TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
small cell lung cancer.
Beschreibung

Small cell carcinoma of lung

Datentyp

boolean

Alias
UMLS CUI [1]
C0149925
poor performance status eastern cooperative oncology group (ecog) 3-4.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
poor pulmonary function precluding radical radiation therapy (adequate pulmonary reserve for radical radiation therapy. pulmonary function tests should have forced expiratory volume in 1 second (fev1) > 1.0 liter or > 40% predicted, diffusing capacity of the lung for carbon monoxide (dlco) > 45% and/or predicted contralateral fev1 > 800 cc based on quantitative ventilation perfusion lung scan).
Beschreibung

Pulmonary function Poor Excludes Therapeutic radiology procedure Radical | Mature Neutrophils Present Lung | Pulmonary function tests | FEV1 | Carbon Monoxide Diffusing Capability Test | FEV1 Contralateral | VQ - Ventilation perfusion scan Quantitative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C1522449
UMLS CUI [1,5]
C0439807
UMLS CUI [2,1]
C1708947
UMLS CUI [2,2]
C0024109
UMLS CUI [3]
C0024119
UMLS CUI [4]
C0748133
UMLS CUI [5]
C1516251
UMLS CUI [6,1]
C0748133
UMLS CUI [6,2]
C0441988
UMLS CUI [7,1]
C0560738
UMLS CUI [7,2]
C0392762
significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease).
Beschreibung

Medical Problem Significant | Diabetic - poor control | cardiac problem | Chronic Obstructive Airway Disease Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0262402
UMLS CUI [4,1]
C0024117
UMLS CUI [4,2]
C0750502
insulin dependent diabetic where requirements for pet imaging may be problematic.
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Problem Positron-Emission Tomography Related

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0033213
UMLS CUI [2,2]
C0032743
UMLS CUI [2,3]
C0439849
unable to lie supine for at least 30 minutes in radiation treatment position for imaging with pet.
Beschreibung

Positron-Emission Tomography Supine Position Duration Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C1299582
failure to provide informed consent.
Beschreibung

Informed Consent failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
previous pet scan relating to recent cancer diagnosis prior to entry into study.
Beschreibung

Positron-Emission Tomography Malignant Neoplasm Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0439849
pregnant or lactating females.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior thoracic radiation.
Beschreibung

History of radiation therapy to chest

Datentyp

boolean

Alias
UMLS CUI [1]
C4038799
prior malignancy within 3 years from randomization (except nonmelanotic skin cancer or carcinoma in situ of the cervix).
Beschreibung

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
administered more than two cycles of chemotherapy prior to radical radiation therapy or concurrent chemoradiation (as part of induction or sequential chemotherapy prior to randomization) for the current malignancy.
Beschreibung

Chemotherapy cycle Quantity | Therapeutic radiology procedure Radical Malignant Neoplasm | Chemoradiotherapy Malignant Neoplasm | Induction Chemotherapy | Chemotherapy Sequential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0439807
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C0436307
UMLS CUI [3,2]
C0006826
UMLS CUI [4]
C3179010
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C1705294
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Ähnliche Modelle

Eligibility Non-Small-Cell Lung Carcinoma NCT00136864

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Evidence of | Squamous cell carcinoma | Adenocarcinoma | Carcinoma, Large Cell | Non-Small Cell Lung Carcinoma NOS
Item
histological or cytological evidence of nsclc. must have documented pathology report with histology indicated (e.g. squamous, adenocarcinoma, large cell, nsclc not otherwise specified).
boolean
C0007131 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0007137 (UMLS CUI [2])
C0001418 (UMLS CUI [3])
C0206704 (UMLS CUI [4])
C0007131 (UMLS CUI [5])
Non-Small Cell Lung Carcinoma | TNM clinical staging | Mediastinal lymph node Positive | Chest CT | CT of upper abdomen | CAT scan of brain | MRI brain procedure | Radioisotope scan of bone
Item
stage iii (mediastinal node positive) nsclc based on conventional staging (e.g. computed tomography [ct] scan of chest and upper abdomen, ct or magnetic resonance imaging [mri] of brain, bone scan).
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
C1279049 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0202823 (UMLS CUI [4])
C1627748 (UMLS CUI [5])
C0412585 (UMLS CUI [6])
C0412675 (UMLS CUI [7])
C0203668 (UMLS CUI [8])
Indication Combined Modality Therapy | Indication Therapeutic radiology procedure Radical | Indication Chemotherapy | Indication Therapeutic radiology procedure | Indication Operative Surgical Procedures
Item
suitable for combined modality (chemotherapy and radiation) therapy or radical radiation therapy or trimodality therapy (chemotherapy, radiation and surgery).
boolean
C3146298 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0439807 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C3146298 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C3146298 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Non-Small Cell Lung Carcinoma | TNM clinical staging
Item
stage iv nsclc (by conventional staging).
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Small cell carcinoma of lung
Item
small cell lung cancer.
boolean
C0149925 (UMLS CUI [1])
ECOG performance status
Item
poor performance status eastern cooperative oncology group (ecog) 3-4.
boolean
C1520224 (UMLS CUI [1])
Pulmonary function Poor Excludes Therapeutic radiology procedure Radical | Mature Neutrophils Present Lung | Pulmonary function tests | FEV1 | Carbon Monoxide Diffusing Capability Test | FEV1 Contralateral | VQ - Ventilation perfusion scan Quantitative
Item
poor pulmonary function precluding radical radiation therapy (adequate pulmonary reserve for radical radiation therapy. pulmonary function tests should have forced expiratory volume in 1 second (fev1) > 1.0 liter or > 40% predicted, diffusing capacity of the lung for carbon monoxide (dlco) > 45% and/or predicted contralateral fev1 > 800 cc based on quantitative ventilation perfusion lung scan).
boolean
C0231921 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
C0439807 (UMLS CUI [1,5])
C1708947 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
C0024119 (UMLS CUI [3])
C0748133 (UMLS CUI [4])
C1516251 (UMLS CUI [5])
C0748133 (UMLS CUI [6,1])
C0441988 (UMLS CUI [6,2])
C0560738 (UMLS CUI [7,1])
C0392762 (UMLS CUI [7,2])
Medical Problem Significant | Diabetic - poor control | cardiac problem | Chronic Obstructive Airway Disease Significant
Item
significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease).
boolean
C1254481 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C0262402 (UMLS CUI [3])
C0024117 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
Diabetes Mellitus, Insulin-Dependent | Problem Positron-Emission Tomography Related
Item
insulin dependent diabetic where requirements for pet imaging may be problematic.
boolean
C0011854 (UMLS CUI [1])
C0033213 (UMLS CUI [2,1])
C0032743 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Positron-Emission Tomography Supine Position Duration Unable
Item
unable to lie supine for at least 30 minutes in radiation treatment position for imaging with pet.
boolean
C0032743 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Informed Consent failed
Item
failure to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Positron-Emission Tomography Malignant Neoplasm Related
Item
previous pet scan relating to recent cancer diagnosis prior to entry into study.
boolean
C0032743 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
History of radiation therapy to chest
Item
prior thoracic radiation.
boolean
C4038799 (UMLS CUI [1])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
prior malignancy within 3 years from randomization (except nonmelanotic skin cancer or carcinoma in situ of the cervix).
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Chemotherapy cycle Quantity | Therapeutic radiology procedure Radical Malignant Neoplasm | Chemoradiotherapy Malignant Neoplasm | Induction Chemotherapy | Chemotherapy Sequential
Item
administered more than two cycles of chemotherapy prior to radical radiation therapy or concurrent chemoradiation (as part of induction or sequential chemotherapy prior to randomization) for the current malignancy.
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0439807 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C0436307 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C3179010 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C1705294 (UMLS CUI [5,2])
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