ID

15664

Beschrijving

Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy (PARTIST) for Locally Advanced, Non-small Cell Lung Cancer With Genomic Driver Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT02277457

Link

https://clinicaltrials.gov/show/NCT02277457

Trefwoorden

Versies (1)
  1. 07-06-16 07-06-16 -
Geüploaded op

7 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02277457

Engels

Eligibility Non-Small Cell Lung Cancer NCT02277457

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with fdg-avid (radioactive glucose) and pathologically proven stage iia-iib or iiia-iiib non-small cell lung cancer (according to ajcc [american joint committee on cancer] staging, 7th edition).
Beschrijving

Non-Small Cell Lung Carcinoma | FDG-Positron Emission Tomography

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3641247
patients with tumors that harbor either egfr sensitizing mutations or alk rearrangement.
Beschrijving

Malignant Neoplasms | EGFR-TKI Sensitizing Mutation | ALK gene Rearrangement

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C3273083
UMLS CUI [3,1]
C1332080
UMLS CUI [3,2]
C0017287
patients must be considered unresectable or medically inoperable; patients who decline surgery are also eligible.
Beschrijving

unresectable | Inoperable | Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C1519810
UMLS CUI [2]
C0205187
UMLS CUI [3]
C0543467
patients must be 18 years of age or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with ecog (eastern cooperative oncology group) performance status of 0-2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patients must have adequate organ function.
Beschrijving

organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
patients must be able to take oral medications.
Beschrijving

Able to swallow oral medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
women with reproductive capability must be willing to use effective contraception.
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
patients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelines.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients must be willing to comply with study procedures.
Beschrijving

Compliance behavior Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with tumors that have a component of small cell carcinoma.
Beschrijving

Malignant Neoplasms Component Carcinoma, Small Cell

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0262584
patients wtih stage i, ii, or iv disease, including malignant pleural or pericardial effusion.
Beschrijving

Malignant Neoplasms | TNM clinical staging | Pleural Effusion, Malignant | Malignant pericardial effusion

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C3258246
UMLS CUI [3]
C0080032
UMLS CUI [4]
C0220655
prior radiotherapy to the thorax such that composite radiation would significantly over-dose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints.
Beschrijving

prior radiation therapy Chest

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0817096
patients who cannot tolerate thoracic radiotherapy or targeted therapy.
Beschrijving

Chest Therapeutic radiology procedure Unable | Targeted Therapy Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0817096
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C1299582
patients wtih a prior diagnosis of interstitial lung disease or pulmonary fibrosis.
Beschrijving

Prior diagnosis Lung Diseases, Interstitial | Prior diagnosis Pulmonary Fibrosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0206062
UMLS CUI [2,1]
C0332132
UMLS CUI [2,2]
C0034069
patients who cannot take oral medication, require intravenous alimentation, had prior surgical procedures affecting gastrointestinal absorption, or have active peptic ulcer disease.
Beschrijving

Able to swallow oral medication | Intravenous Feeding | Operative Surgical Procedures Affecting Gastrointestinal Absorption | Peptic Ulcer

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2]
C0021910
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C3714657
UMLS CUI [4]
C0030920
hypersensitivity to erlotinib, crizotinib, or to any of the excipients.
Beschrijving

Hypersensitivity erlotinib | Hypersensitivity crizotinib | Hypersensitivity Pharmaceutical Excipient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2974289
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0015237
pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
Beschrijving

Pregnancy | Therapeutic radiology procedure Teratogenic effect | Therapeutic radiology procedure Abortifacient Effect

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0232910
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C3179338
prisoners are excluded from this study.
Beschrijving

Prisoners

Datatype

boolean

Alias
UMLS CUI [1]
C0033167
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02277457

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | FDG-Positron Emission Tomography
Item
patients with fdg-avid (radioactive glucose) and pathologically proven stage iia-iib or iiia-iiib non-small cell lung cancer (according to ajcc [american joint committee on cancer] staging, 7th edition).
boolean
C0007131 (UMLS CUI [1])
C3641247 (UMLS CUI [2])
Malignant Neoplasms | EGFR-TKI Sensitizing Mutation | ALK gene Rearrangement
Item
patients with tumors that harbor either egfr sensitizing mutations or alk rearrangement.
boolean
C0006826 (UMLS CUI [1])
C3273083 (UMLS CUI [2])
C1332080 (UMLS CUI [3,1])
C0017287 (UMLS CUI [3,2])
unresectable | Inoperable | Operative Surgical Procedures
Item
patients must be considered unresectable or medically inoperable; patients who decline surgery are also eligible.
boolean
C1519810 (UMLS CUI [1])
C0205187 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Age
Item
patients must be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
patients with ecog (eastern cooperative oncology group) performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
organ function
Item
patients must have adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Able to swallow oral medication
Item
patients must be able to take oral medications.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
women with reproductive capability must be willing to use effective contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed consent
Item
patients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Study Protocol
Item
patients must be willing to comply with study procedures.
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms Component Carcinoma, Small Cell
Item
patients with tumors that have a component of small cell carcinoma.
boolean
C0006826 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0262584 (UMLS CUI [1,3])
Malignant Neoplasms | TNM clinical staging | Pleural Effusion, Malignant | Malignant pericardial effusion
Item
patients wtih stage i, ii, or iv disease, including malignant pleural or pericardial effusion.
boolean
C0006826 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
C0080032 (UMLS CUI [3])
C0220655 (UMLS CUI [4])
prior radiation therapy Chest
Item
prior radiotherapy to the thorax such that composite radiation would significantly over-dose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints.
boolean
C0279134 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
Chest Therapeutic radiology procedure Unable | Targeted Therapy Unable
Item
patients who cannot tolerate thoracic radiotherapy or targeted therapy.
boolean
C0817096 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C2985566 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Prior diagnosis Lung Diseases, Interstitial | Prior diagnosis Pulmonary Fibrosis
Item
patients wtih a prior diagnosis of interstitial lung disease or pulmonary fibrosis.
boolean
C0332132 (UMLS CUI [1,1])
C0206062 (UMLS CUI [1,2])
C0332132 (UMLS CUI [2,1])
C0034069 (UMLS CUI [2,2])
Able to swallow oral medication | Intravenous Feeding | Operative Surgical Procedures Affecting Gastrointestinal Absorption | Peptic Ulcer
Item
patients who cannot take oral medication, require intravenous alimentation, had prior surgical procedures affecting gastrointestinal absorption, or have active peptic ulcer disease.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0021910 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C3714657 (UMLS CUI [3,3])
C0030920 (UMLS CUI [4])
Hypersensitivity erlotinib | Hypersensitivity crizotinib | Hypersensitivity Pharmaceutical Excipient
Item
hypersensitivity to erlotinib, crizotinib, or to any of the excipients.
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2974289 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
Pregnancy | Therapeutic radiology procedure Teratogenic effect | Therapeutic radiology procedure Abortifacient Effect
Item
pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
boolean
C0032961 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0232910 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C3179338 (UMLS CUI [3,2])
Prisoners
Item
prisoners are excluded from this study.
boolean
C0033167 (UMLS CUI [1])
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