ID

36686

Description

Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02394548

Link

https://clinicaltrials.gov/show/NCT02394548

Keywords

Versions (1)
  1. 6/1/19 6/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Carcinoma NCT02394548

English

Eligibility Non-small Cell Lung Carcinoma NCT02394548

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must meet the following criteria on screening examination to be eligible to participate in the study.
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
histologically or cytologically proven diagnosis of nsclc or sclc
Description

Non-Small Cell Lung Carcinoma | Small cell carcinoma of lung

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0149925
nsclc, patients with clinical stage iib-iv patients (ajcc, 7th ed.) are eligible, and for sclc, limited-stage patients are eligible, if documented to be a candidate for definitive radiation and concurrent chemotherapy in the radiation oncologist or medical oncologist clinic note.
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Small cell carcinoma of lung Appropriate Therapeutic radiology procedure | Small cell carcinoma of lung Appropriate Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0149925
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C1522449
UMLS CUI [3,1]
C0149925
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0392920
stage iv nsclc patients are eligible only if they have a solitary brain metastasis
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Metastatic malignant neoplasm to brain Solitary

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205171
patients with non-malignant pleural effusion are eligible. --- if a pleural effusion is present, the following criteria must be met to exclude malignant involvement:
Description

Non-Malignant Pleural Effusion

Data type

boolean

Alias
UMLS CUI [1]
C1557756
when pleural fluid is visible on both the ct scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
Description

Pleural fluid Visible CT scan | Pleural fluid Visible Chest X-ray | Pleurocentesis Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0225778
UMLS CUI [1,2]
C0205379
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0225778
UMLS CUI [2,2]
C0205379
UMLS CUI [2,3]
C0039985
UMLS CUI [3,1]
C0189477
UMLS CUI [3,2]
C1514873
exudative pleural effusions are excluded, regardless of cytology;
Description

Exudative pleural effusion Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3887491
UMLS CUI [1,2]
C0332196
effusions that are minimal (ie, not visible on chest x-ray) that are too small to safely tap are eligible.
Description

Effusion Minimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0013687
UMLS CUI [1,2]
C0547040
gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus on the most recent chest ct scan.
Description

Tumor Gross Esophagus Chest CT | Primary tumor Chest CT | Lymph Node Involvement Chest CT

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0439806
UMLS CUI [1,3]
C0014876
UMLS CUI [1,4]
C0202823
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0202823
UMLS CUI [3,1]
C0806692
UMLS CUI [3,2]
C0202823
ecog performance status 0-1 within 30 days prior to registration;
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age ≥18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential must indicate that there is not a possibility of being pregnant at the time of enrollment or have a negative serum pregnancy test prior to the initiation of radiation therapy.
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
women of childbearing potential and male participants must practice adequate contraception.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
patient must provide study-specific informed consent prior to study entry.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
Description

Condition Ineligibility

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1512714
greater than minimal, exudative, or cytologically positive pleural effusions
Description

Pleural effusion Greater Than Minimum | Exudative pleural effusion | Pleural effusion Positive Cytology

Data type

boolean

Alias
UMLS CUI [1,1]
C1253943
UMLS CUI [1,2]
C0439093
UMLS CUI [1,3]
C1524031
UMLS CUI [2]
C3887491
UMLS CUI [3,1]
C1253943
UMLS CUI [3,2]
C1514241
UMLS CUI [3,3]
C1305671
tumor suspected or known to invade the esophagus
Description

Tumor Invasion Suspected Esophagus | Tumor Invasion Esophagus

Data type

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0750491
UMLS CUI [1,3]
C0014876
UMLS CUI [2,1]
C1269955
UMLS CUI [2,2]
C0014876
prior chemotherapy if this precludes administration of concurrent chemotherapy for protocol treatment. note that induction chemotherapy is allowed as long as concurrent chemotherapy is possible.
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Description

Prior radiation therapy Body Region Same

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005898
UMLS CUI [1,3]
C0445247
acquired immune deficiency syndrome (aids) based upon current cdc definition; note, however, that hiv testing is not required for entry into this protocol. the need to exclude patients with aids from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. protocol-specific requirements may also exclude immuno-compromised patients.
Description

Acquired Immunodeficiency Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0001175
pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Description

Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Gender Sexually active Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C0558080
any history of allergic reaction to chemotherapies used
Description

Allergic Reaction Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0392920
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Similar models

Eligibility Non-small Cell Lung Carcinoma NCT02394548

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
participants must meet the following criteria on screening examination to be eligible to participate in the study.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma | Small cell carcinoma of lung
Item
histologically or cytologically proven diagnosis of nsclc or sclc
boolean
C0007131 (UMLS CUI [1])
C0149925 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma TNM clinical staging | Small cell carcinoma of lung Appropriate Therapeutic radiology procedure | Small cell carcinoma of lung Appropriate Chemotherapy
Item
nsclc, patients with clinical stage iib-iv patients (ajcc, 7th ed.) are eligible, and for sclc, limited-stage patients are eligible, if documented to be a candidate for definitive radiation and concurrent chemotherapy in the radiation oncologist or medical oncologist clinic note.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0149925 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C0149925 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Non-Small Cell Lung Carcinoma TNM clinical staging | Metastatic malignant neoplasm to brain Solitary
Item
stage iv nsclc patients are eligible only if they have a solitary brain metastasis
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Non-Malignant Pleural Effusion
Item
patients with non-malignant pleural effusion are eligible. --- if a pleural effusion is present, the following criteria must be met to exclude malignant involvement:
boolean
C1557756 (UMLS CUI [1])
Pleural fluid Visible CT scan | Pleural fluid Visible Chest X-ray | Pleurocentesis Required
Item
when pleural fluid is visible on both the ct scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
boolean
C0225778 (UMLS CUI [1,1])
C0205379 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0225778 (UMLS CUI [2,1])
C0205379 (UMLS CUI [2,2])
C0039985 (UMLS CUI [2,3])
C0189477 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Exudative pleural effusion Excluded
Item
exudative pleural effusions are excluded, regardless of cytology;
boolean
C3887491 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Effusion Minimal
Item
effusions that are minimal (ie, not visible on chest x-ray) that are too small to safely tap are eligible.
boolean
C0013687 (UMLS CUI [1,1])
C0547040 (UMLS CUI [1,2])
Tumor Gross Esophagus Chest CT | Primary tumor Chest CT | Lymph Node Involvement Chest CT
Item
gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus on the most recent chest ct scan.
boolean
C0027651 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
C0014876 (UMLS CUI [1,3])
C0202823 (UMLS CUI [1,4])
C0677930 (UMLS CUI [2,1])
C0202823 (UMLS CUI [2,2])
C0806692 (UMLS CUI [3,1])
C0202823 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status 0-1 within 30 days prior to registration;
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥18
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
women of childbearing potential must indicate that there is not a possibility of being pregnant at the time of enrollment or have a negative serum pregnancy test prior to the initiation of radiation therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
women of childbearing potential and male participants must practice adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
patient must provide study-specific informed consent prior to study entry.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Condition Ineligibility
Item
participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
boolean
C0348080 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Pleural effusion Greater Than Minimum | Exudative pleural effusion | Pleural effusion Positive Cytology
Item
greater than minimal, exudative, or cytologically positive pleural effusions
boolean
C1253943 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C3887491 (UMLS CUI [2])
C1253943 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C1305671 (UMLS CUI [3,3])
Tumor Invasion Suspected Esophagus | Tumor Invasion Esophagus
Item
tumor suspected or known to invade the esophagus
boolean
C1269955 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0014876 (UMLS CUI [1,3])
C1269955 (UMLS CUI [2,1])
C0014876 (UMLS CUI [2,2])
Prior Chemotherapy
Item
prior chemotherapy if this precludes administration of concurrent chemotherapy for protocol treatment. note that induction chemotherapy is allowed as long as concurrent chemotherapy is possible.
boolean
C1514457 (UMLS CUI [1])
Prior radiation therapy Body Region Same
Item
prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
boolean
C0279134 (UMLS CUI [1,1])
C0005898 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
Acquired Immunodeficiency Syndrome
Item
acquired immune deficiency syndrome (aids) based upon current cdc definition; note, however, that hiv testing is not required for entry into this protocol. the need to exclude patients with aids from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. protocol-specific requirements may also exclude immuno-compromised patients.
boolean
C0001175 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Gender Sexually active Contraceptive methods Unwilling
Item
pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
Allergic Reaction Chemotherapy
Item
any history of allergic reaction to chemotherapies used
boolean
C1527304 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
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