ID

36669

Description

Pilot Study of a Novel Type of CT Scan to Assess Treatment Response During Chemoradiotherapy for Stage III Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02053285

Link

https://clinicaltrials.gov/show/NCT02053285

Keywords

Versions (1)
  1. 5/31/19 5/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer Stage III NCT02053285

English

Eligibility Non-small Cell Lung Cancer Stage III NCT02053285

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged greater than 18 years with a diagnosis of stage iii non-small cell lung cancer.
Description

Age | Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection.
Description

Chemoradiotherapy Planned | Chemoradiotherapy Preoperative Planned | Excision Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0436307
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0436307
UMLS CUI [2,2]
C0445204
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C1301732
pet-ct study within 4 weeks of next available dect study.
Description

PET/CT Study | DECT Study

Data type

boolean

Alias
UMLS CUI [1,1]
C1699633
UMLS CUI [1,2]
C2603343
UMLS CUI [2,1]
C4055114
UMLS CUI [2,2]
C2603343
patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm.
Description

Measurable Disease Primary | Disorder of lymph node Primary | Primary lesion Size Quantity | Lymph node Primary lesion Size Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0272394
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C1402294
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0024204
UMLS CUI [4,2]
C1402294
UMLS CUI [4,3]
C0456389
UMLS CUI [4,4]
C1265611
kidney function sufficient to tolerate iodine-based ct contrast.
Description

Renal function | CT iodinated contrast dye

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2,1]
C0040405
UMLS CUI [2,2]
C0879373
no allergy to iodine-based contrast.
Description

Iodine contrast allergy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4022917
UMLS CUI [1,2]
C0332197
ability to understand and the willingness to sign informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with a prior history of thoracic radiotherapy.
Description

Radiotherapy to thorax

Data type

boolean

Alias
UMLS CUI [1]
C4038705
participants may not be receiving any other study agents.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
inability to tolerate ct contrast
Description

CT scan contrast Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0742919
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. these potential risks may also apply to other agents used in this study.
Description

Pregnancy | Breast Feeding To be stopped

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1272691
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Similar models

Eligibility Non-small Cell Lung Cancer Stage III NCT02053285

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Non-Small Cell Lung Carcinoma TNM clinical staging
Item
patients aged greater than 18 years with a diagnosis of stage iii non-small cell lung cancer.
boolean
C0001779 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Chemoradiotherapy Planned | Chemoradiotherapy Preoperative Planned | Excision Planned
Item
planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection.
boolean
C0436307 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0436307 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0728940 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
PET/CT Study | DECT Study
Item
pet-ct study within 4 weeks of next available dect study.
boolean
C1699633 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C4055114 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
Measurable Disease Primary | Disorder of lymph node Primary | Primary lesion Size Quantity | Lymph node Primary lesion Size Quantity
Item
patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm.
boolean
C1513041 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0272394 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C1402294 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0024204 (UMLS CUI [4,1])
C1402294 (UMLS CUI [4,2])
C0456389 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Renal function | CT iodinated contrast dye
Item
kidney function sufficient to tolerate iodine-based ct contrast.
boolean
C0232804 (UMLS CUI [1])
C0040405 (UMLS CUI [2,1])
C0879373 (UMLS CUI [2,2])
Iodine contrast allergy Absent
Item
no allergy to iodine-based contrast.
boolean
C4022917 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and the willingness to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to thorax
Item
participants with a prior history of thoracic radiotherapy.
boolean
C4038705 (UMLS CUI [1])
Investigational New Drugs
Item
participants may not be receiving any other study agents.
boolean
C0013230 (UMLS CUI [1])
CT scan contrast Receive Unable
Item
inability to tolerate ct contrast
boolean
C0742919 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Pregnancy | Breast Feeding To be stopped
Item
pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. these potential risks may also apply to other agents used in this study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
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