ID

12423

Descripción

Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02106988

Link

https://clinicaltrials.gov/show/NCT02106988

Palabras clave

Versiones (1)
  1. 17/11/15 17/11/15 -
Subido en

17 de noviembre de 2015

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma NCT02106988

Inglés

Eligibility Lymphoma NCT02106988

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02106988
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with newly diagnosed stage i and ii nasal nk cell lymphoma.
Descripción

Nasal nk cell lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392788
2. adequate blood cell counts (i.e. anc > 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and epoetin.
Descripción

Adequate blood cell count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005771
UMLS CUI [2]
C1879316
3. patients must have adequate liver function as indicated by: *bilirubin </= 1.5 times the upper limit of normal (uln), * alanine transaminase (alt) </= 2 times the (uln) or aspartate transaminase (ast) </= 2 times the uln, *these values must be obtained within two weeks before protocol entry.
Descripción

Adequate liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
4. patients are required to have a serum creatinine </= 2.0 mg/dl. this value must be obtained within two weeks before protocol entry.
Descripción

Serum creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0600061
5. left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >/= 50%.
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
6. male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
Descripción

Barrier method of contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004764
UMLS CUI [2]
C3840693
7. female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
Descripción

Barrier methods of contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3840693
UMLS CUI [2]
C0558251
8. female patients of childbearing potential must have a negative serum pregnancy test (bhcg) within 2 weeks of protocol entry.
Descripción

Negative serum pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430061
9. patients must have the ability to give informed consent.
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with active hepatitis b and/or hepatitis c infection.
Descripción

Hepatitis B and hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2711110
2. patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
Descripción

Anti-infective therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1141958
3. patients known to be hiv positive.
Descripción

Hiv positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
4. patients with pre-existing cardiovascular disease requiring ongoing treatment. this includes: a) congestive heart failure class iii/iv chf per new york heart association (nyha) criteria. b) cardiomyopathy, c) uncontrolled cardiac arrhythmia, d) unstable angina pectoris, e) recent mi (within 6 months).
Descripción

Cardiovascular Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
5. patients who are pregnant or breast-feeding.
Descripción

Pregnant or breast-feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3242212
6. patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
Descripción

Mental disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C1709261
7. prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site.
Descripción

Prior radiation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
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Similar models

Eligibility Lymphoma NCT02106988

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02106988
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Nasal nk cell lymphoma
Item
1. patients with newly diagnosed stage i and ii nasal nk cell lymphoma.
boolean
C0392788 (UMLS CUI [1])
Adequate blood cell count
Item
2. adequate blood cell counts (i.e. anc > 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and epoetin.
boolean
C0005771 (UMLS CUI [1])
C1879316 (UMLS CUI [2])
Adequate liver function
Item
3. patients must have adequate liver function as indicated by: *bilirubin </= 1.5 times the upper limit of normal (uln), * alanine transaminase (alt) </= 2 times the (uln) or aspartate transaminase (ast) </= 2 times the uln, *these values must be obtained within two weeks before protocol entry.
boolean
C0232741 (UMLS CUI [1])
Serum creatinine
Item
4. patients are required to have a serum creatinine </= 2.0 mg/dl. this value must be obtained within two weeks before protocol entry.
boolean
C0600061 (UMLS CUI [1])
Left ventricular ejection fraction
Item
5. left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >/= 50%.
boolean
C0428772 (UMLS CUI [1])
Barrier method of contraception
Item
6. male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
boolean
C0004764 (UMLS CUI [1])
C3840693 (UMLS CUI [2])
Barrier methods of contraception
Item
7. female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
boolean
C3840693 (UMLS CUI [1])
C0558251 (UMLS CUI [2])
Negative serum pregnancy test
Item
8. female patients of childbearing potential must have a negative serum pregnancy test (bhcg) within 2 weeks of protocol entry.
boolean
C0430061 (UMLS CUI [1])
Informed consent
Item
9. patients must have the ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis B and hepatitis C
Item
1. patients with active hepatitis b and/or hepatitis c infection.
boolean
C2711110 (UMLS CUI [1])
Anti-infective therapy
Item
2. patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
boolean
C1141958 (UMLS CUI [1])
Hiv positive
Item
3. patients known to be hiv positive.
boolean
C0019699 (UMLS CUI [1])
Cardiovascular Diseases
Item
4. patients with pre-existing cardiovascular disease requiring ongoing treatment. this includes: a) congestive heart failure class iii/iv chf per new york heart association (nyha) criteria. b) cardiomyopathy, c) uncontrolled cardiac arrhythmia, d) unstable angina pectoris, e) recent mi (within 6 months).
boolean
C0007222 (UMLS CUI [1])
Pregnant or breast-feeding
Item
5. patients who are pregnant or breast-feeding.
boolean
C3242212 (UMLS CUI [1])
Mental disorders
Item
6. patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
boolean
C0004936 (UMLS CUI [1])
C1709261 (UMLS CUI [2])
Prior radiation
Item
7. prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site.
boolean
C1522449 (UMLS CUI [1])
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