ID

40087

Beschreibung

5-FU Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01658813

Link

https://clinicaltrials.gov/show/NCT01658813

Stichworte

Versionen (2)
  1. 20.12.19 20.12.19 -
  2. 12.03.20 12.03.20 - Sarah Riepenhausen
Rechteinhaber

Western Regional Medical Center

Hochgeladen am

12. März 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Interferon-alfa-2b after 5-FU in Metastatic Gastrointestinal, Kidney, or Lung Cancer, NCT01658813

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically-proven, metastatic gastrointestinal, kidney, or lung cancer who have had disease progression on at least two prior systemic therapies.
Beschreibung

Gastrointestinal cancer metastatic | Malignant neoplasm of kidney | Malignant neoplasm of lung | Disease Progression | Systemic therapy Previous Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C1096061
UMLS CUI [2]
C0740457
UMLS CUI [3]
C0242379
UMLS CUI [4]
C0242656
UMLS CUI [5,1]
C1515119
UMLS CUI [5,2]
C0205156
UMLS CUI [5,3]
C1265611
ecog performance status of 0, 1, or 2 and estimated survival of at least 3 months.
Beschreibung

ECOG performance status | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
patients must be felt to have recovered from effects of prior therapy, such as past expected wbc nadir for chemotherapy (> 2 weeks for most agents, > 6 weeks for nitrosoureas or mitomycin-c)
Beschreibung

Effects of Prior Therapy | Patient recovered | White Blood Cell Count Nadir Chemotherapy | Nitrosoureas | Mitomycin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704420
UMLS CUI [1,2]
C1514463
UMLS CUI [2]
C1115804
UMLS CUI [3,1]
C0023508
UMLS CUI [3,2]
C1708760
UMLS CUI [3,3]
C0392920
UMLS CUI [4]
C0028210
UMLS CUI [5]
C0002475
patient consent must be obtained prior to entrance onto study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
white blood count > 3500/mm3; platelet count of at least 100,000/mm3; hemoglobin > 9.0 gm/dl; bilirubin, ast, alt less than 3 times the upper limit of normal; serum creatinine < 1.8.
Beschreibung

White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201976
corticosteroids and immunosuppressive agents are not permitted during the course of the study. patients must have received no corticosteroids or immunosuppressive medications at least 2 weeks prior to entrance on-study.
Beschreibung

Adrenal Cortex Hormones Absent | Immunosuppressive Agents Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0332197
patients with elevated temperatures > 100.5 degrees f, must have sources of occult infection excluded.
Beschreibung

Fever | Communicable Disease Occult Excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205262
UMLS CUI [2,3]
C0332196
women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment.
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional pvc's, angina, or cerebrovascular accident.
Beschreibung

Cardiovascular Diseases | Myocardial Infarction | Congestive heart failure Uncompensated | Cardiac Arrhythmia Primary | Independent of Electrolyte disorder | Independent of Drug toxicity | Premature ventricular contractions occasional | Angina Pectoris | Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205433
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205225
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0342579
UMLS CUI [6,1]
C0332291
UMLS CUI [6,2]
C0013221
UMLS CUI [7,1]
C0151636
UMLS CUI [7,2]
C0521114
UMLS CUI [8]
C0002962
UMLS CUI [9]
C0038454
prior history of psychiatric disorder that could be exacerbated by interferon therapy or which could preclude completion of this therapy.
Beschreibung

Mental disorder Exacerbated Due to Interferon therapy | Mental disorder Excludes Completion Interferon therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1444749
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0279030
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C0279030
pregnancy or lactation.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of hypersensitivity to interferon alfa or fluoropyrimidines.
Beschreibung

Hypersensitivity Interferon-alpha | Hypersensitivity fluoropyrimidine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002199
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0596581
history of severe debilitating pulmonary disease, such as chronic obstructive pulmonary disease requiring continuous oxygen therapy.
Beschreibung

Lung disease Severe Resulting in Debilitation | Chronic Obstructive Airway Disease | Requirement Oxygen Therapy Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332294
UMLS CUI [1,4]
C0742985
UMLS CUI [2]
C0024117
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0184633
UMLS CUI [3,3]
C0549178
history of autoimmune disease requiring immunosuppression.
Beschreibung

Autoimmune Disease Requirement Therapeutic immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
documented inflammatory joint or systemic inflammatory disease (such as lupus) which could be exacerbated by interferon therapy.
Beschreibung

inflammatory joint disease | Inflammatory disorder Systemic | Lupus Erythematosus, Systemic | Exacerbation Due to Interferon therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1290884
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0024141
UMLS CUI [4,1]
C4086268
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0279030
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gastrointestinal cancer metastatic | Malignant neoplasm of kidney | Malignant neoplasm of lung | Disease Progression | Systemic therapy Previous Quantity
Item
patients must have histologically-proven, metastatic gastrointestinal, kidney, or lung cancer who have had disease progression on at least two prior systemic therapies.
boolean
C1096061 (UMLS CUI [1])
C0740457 (UMLS CUI [2])
C0242379 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C1515119 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
ECOG performance status | Life Expectancy
Item
ecog performance status of 0, 1, or 2 and estimated survival of at least 3 months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Effects of Prior Therapy | Patient recovered | White Blood Cell Count Nadir Chemotherapy | Nitrosoureas | Mitomycin
Item
patients must be felt to have recovered from effects of prior therapy, such as past expected wbc nadir for chemotherapy (> 2 weeks for most agents, > 6 weeks for nitrosoureas or mitomycin-c)
boolean
C1704420 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1115804 (UMLS CUI [2])
C0023508 (UMLS CUI [3,1])
C1708760 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0028210 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
Informed Consent
Item
patient consent must be obtained prior to entrance onto study.
boolean
C0021430 (UMLS CUI [1])
White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum
Item
white blood count > 3500/mm3; platelet count of at least 100,000/mm3; hemoglobin > 9.0 gm/dl; bilirubin, ast, alt less than 3 times the upper limit of normal; serum creatinine < 1.8.
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Adrenal Cortex Hormones Absent | Immunosuppressive Agents Absent
Item
corticosteroids and immunosuppressive agents are not permitted during the course of the study. patients must have received no corticosteroids or immunosuppressive medications at least 2 weeks prior to entrance on-study.
boolean
C0001617 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Fever | Communicable Disease Occult Excluded
Item
patients with elevated temperatures > 100.5 degrees f, must have sources of occult infection excluded.
boolean
C0015967 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205262 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases | Myocardial Infarction | Congestive heart failure Uncompensated | Cardiac Arrhythmia Primary | Independent of Electrolyte disorder | Independent of Drug toxicity | Premature ventricular contractions occasional | Angina Pectoris | Cerebrovascular accident
Item
evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional pvc's, angina, or cerebrovascular accident.
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205433 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C0332291 (UMLS CUI [5,1])
C0342579 (UMLS CUI [5,2])
C0332291 (UMLS CUI [6,1])
C0013221 (UMLS CUI [6,2])
C0151636 (UMLS CUI [7,1])
C0521114 (UMLS CUI [7,2])
C0002962 (UMLS CUI [8])
C0038454 (UMLS CUI [9])
Mental disorder Exacerbated Due to Interferon therapy | Mental disorder Excludes Completion Interferon therapy
Item
prior history of psychiatric disorder that could be exacerbated by interferon therapy or which could preclude completion of this therapy.
boolean
C0004936 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0279030 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0279030 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Interferon-alpha | Hypersensitivity fluoropyrimidine
Item
history of hypersensitivity to interferon alfa or fluoropyrimidines.
boolean
C0020517 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0596581 (UMLS CUI [2,2])
Lung disease Severe Resulting in Debilitation | Chronic Obstructive Airway Disease | Requirement Oxygen Therapy Continuous
Item
history of severe debilitating pulmonary disease, such as chronic obstructive pulmonary disease requiring continuous oxygen therapy.
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332294 (UMLS CUI [1,3])
C0742985 (UMLS CUI [1,4])
C0024117 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0184633 (UMLS CUI [3,2])
C0549178 (UMLS CUI [3,3])
Autoimmune Disease Requirement Therapeutic immunosuppression
Item
history of autoimmune disease requiring immunosuppression.
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
inflammatory joint disease | Inflammatory disorder Systemic | Lupus Erythematosus, Systemic | Exacerbation Due to Interferon therapy
Item
documented inflammatory joint or systemic inflammatory disease (such as lupus) which could be exacerbated by interferon therapy.
boolean
C0683381 (UMLS CUI [1])
C1290884 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0024141 (UMLS CUI [3])
C4086268 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0279030 (UMLS CUI [4,3])
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