ID

17936

Descripción

Carboplatin and Docetaxel After Surgery in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00280735

Link

https://clinicaltrials.gov/show/NCT00280735

Palabras clave

Versiones (1)
  1. 10/10/16 10/10/16 -
Subido en

10 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00280735

Inglés

Eligibility Lung Cancer NCT00280735

1 formularios  
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed non-small cell lung cancer
Descripción

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
stage i-iiia disease
Descripción

TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3258246
must have undergone a complete resection
Descripción

Complete excision Received

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015250
UMLS CUI [1,2]
C1514756
must begin adjuvant chemotherapy within 8 weeks of surgical resection
Descripción

Adjuvant Chemotherapy Started | Excision

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C1272689
UMLS CUI [2]
C0728940
patient characteristics:
Descripción

Client Characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count ≥ 1,500/mm^3
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin ≥ 8.0 g/dl
Descripción

Hemoglobin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019046
platelet count ≥ 100,000/mm^3
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine normal or creatinine clearance ≥ 40 ml/min
Descripción

Serum creatinine normal | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438244
UMLS CUI [2]
C0373595
bilirubin normal
Descripción

Bilirubin normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0858307
alkaline phosphatase (ap), ast, and alt must meet 1 of the following criteria:
Descripción

Alkaline Phosphatase | Aspartate Transaminase | Alanine Transaminase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002059
UMLS CUI [2]
C0004002
UMLS CUI [3]
C0001899
ap normal and ast and alt ≤ 5 times upper limit of normal (uln)
Descripción

Alkaline phosphatase normal | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0858306
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
ap ≤ 2.5 times uln and ast and alt ≤ 1.5 times uln
Descripción

Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
ap ≤ 5 times uln and ast and alt normal
Descripción

Alkaline phosphatase measurement | Aspartate aminotransferase normal | Alanine aminotransferase normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0855624
UMLS CUI [3]
C0855620
negative pregnancy test
Descripción

Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception during and for at least 3 months after study therapy
Descripción

Fertility Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no breastfeeding
Descripción

Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
no peripheral neuropathy ≥ grade 2
Descripción

Peripheral Neuropathy | CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
no history of severe hypersensitivity to docetaxel or polysorbate 80
Descripción

severe allergy docetaxel | severe allergy Polysorbate 80

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0032601
prior history of malignancy allowed provided the attending medical oncologists believes that adjuvant chemotherapy is indicated and will potentially benefit the patient
Descripción

Malignant Neoplasms | Indication Chemotherapy, Adjuvant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0085533
prior concurrent therapy:
Descripción

Prior Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514463
2-8 weeks since prior surgery and recovered
Descripción

Operative Surgical Procedure | Patient Recovered

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0521108
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Similar models

Eligibility Lung Cancer NCT00280735

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging
Item
stage i-iiia disease
boolean
C3258246 (UMLS CUI [1])
Complete excision Received
Item
must have undergone a complete resection
boolean
C0015250 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
Adjuvant Chemotherapy Started | Excision
Item
must begin adjuvant chemotherapy within 8 weeks of surgical resection
boolean
C0085533 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count ≥ 1,500/mm^3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin ≥ 8.0 g/dl
boolean
C0019046 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum creatinine normal | Creatinine clearance measurement
Item
serum creatinine normal or creatinine clearance ≥ 40 ml/min
boolean
C0438244 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Bilirubin normal
Item
bilirubin normal
boolean
C0858307 (UMLS CUI [1])
Alkaline Phosphatase | Aspartate Transaminase | Alanine Transaminase
Item
alkaline phosphatase (ap), ast, and alt must meet 1 of the following criteria:
boolean
C0002059 (UMLS CUI [1])
C0004002 (UMLS CUI [2])
C0001899 (UMLS CUI [3])
Alkaline phosphatase normal | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ap normal and ast and alt ≤ 5 times upper limit of normal (uln)
boolean
C0858306 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ap ≤ 2.5 times uln and ast and alt ≤ 1.5 times uln
boolean
C0201850 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Alkaline phosphatase measurement | Aspartate aminotransferase normal | Alanine aminotransferase normal
Item
ap ≤ 5 times uln and ast and alt normal
boolean
C0201850 (UMLS CUI [1])
C0855624 (UMLS CUI [2])
C0855620 (UMLS CUI [3])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for at least 3 months after study therapy
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Breast Feeding
Item
no breastfeeding
boolean
C0006147 (UMLS CUI [1])
Peripheral Neuropathy | CTCAE Grades
Item
no peripheral neuropathy ≥ grade 2
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
severe allergy docetaxel | severe allergy Polysorbate 80
Item
no history of severe hypersensitivity to docetaxel or polysorbate 80
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
Malignant Neoplasms | Indication Chemotherapy, Adjuvant
Item
prior history of malignancy allowed provided the attending medical oncologists believes that adjuvant chemotherapy is indicated and will potentially benefit the patient
boolean
C0006826 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0085533 (UMLS CUI [2,2])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Operative Surgical Procedure | Patient Recovered
Item
2-8 weeks since prior surgery and recovered
boolean
C0543467 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
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