ID

22002

Beschreibung

Gemcitabine Plus Oxaliplatin in Advanced Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00453115

Link

https://clinicaltrials.gov/show/NCT00453115

Stichworte

Versionen (1)
  1. 14.05.17 14.05.17 -
Hochgeladen am

14. Mai 2017

DOI

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Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00453115

Englisch

Eligibility Lung Cancer NCT00453115

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologic or cytologic diagnosis of nsclc, stage iv or selected stage iiib (with positive pleural effusion or separate tumor nodules in the same lobe) according to the american joint committee on cancer (ajcc).
Beschreibung

nsclc ajcc stage, pleural effusion, multiple nodules

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0441915
UMLS CUI [1,3]
C0032227
UMLS CUI [1,4]
C0748164
2. no prior chemotherapy.
Beschreibung

prior chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
3. prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
Beschreibung

prior radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279134
4. no other forms of cancer therapy, such as radiation, immunotherapy for at least 4 weeks before the enrollment in study.
Beschreibung

other cancer therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
5. performance status of 0, 1, 2 on the ecog criteria.
Beschreibung

ecog

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. at least one unidimensional measurable lesion meeting response evaluation criteria in solid tumors (recist. 2000).
Beschreibung

response evaluation criteria in solid tumors

Datentyp

boolean

Alias
UMLS CUI [1]
C1709926
7. estimated life expectancy of at least 12 weeks.
Beschreibung

life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
8. patient compliance that allow adequate follow-up.
Beschreibung

follow-up compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
9. adequate organ function including the following:adequate hematologic function: wbc count ≥ 3,500/ul, absolute neutrophil count (anc) ≥ 1,500/ul, and platelet count ≥ 100,000/uladequate hepatic function: bilirubin ≤ 1.5 x unl, alt or ast ≤ 2.5 x unl.adequate renal function: creatinine ≤ 1.5mg/dl.
Beschreibung

hematologic, hepatic, renal function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C0948762
UMLS CUI [1,4]
C0005821
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C1278039
UMLS CUI [2,3]
C0201899
UMLS CUI [2,4]
C0201836
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0201976
10. informed consent from patient
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
11. males or females at least 18 years old.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
12. if female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [iud], birth control pills, or barrier device) during and for 3 months after trial. if male, use of an approved contraceptive method during the study and 3 months afterwards. females with childbearing potential must have a urine negative hcg test within 7 days prior to the study registration.
Beschreibung

effective contraception, pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0032976
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. mi within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
Beschreibung

heart diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
2. serious concomitant infection including post obstructive pneumonia
Beschreibung

infections

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
3. second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
Beschreibung

second primary malignancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0751623
4. pregnant or nursing women
Beschreibung

pregnancy, breast feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. psychiatric disorder that would preclude compliance.
Beschreibung

psychiatric disorder, compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
6. major surgery other than biopsy within the past two weeks.
Beschreibung

major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
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Ähnliche Modelle

Eligibility Lung Cancer NCT00453115

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
nsclc ajcc stage, pleural effusion, multiple nodules
Item
1. histologic or cytologic diagnosis of nsclc, stage iv or selected stage iiib (with positive pleural effusion or separate tumor nodules in the same lobe) according to the american joint committee on cancer (ajcc).
boolean
C0007131 (UMLS CUI [1,1])
C0441915 (UMLS CUI [1,2])
C0032227 (UMLS CUI [1,3])
C0748164 (UMLS CUI [1,4])
prior chemotherapy
Item
2. no prior chemotherapy.
boolean
C1514457 (UMLS CUI [1])
prior radiotherapy
Item
3. prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
boolean
C0279134 (UMLS CUI [1])
other cancer therapy
Item
4. no other forms of cancer therapy, such as radiation, immunotherapy for at least 4 weeks before the enrollment in study.
boolean
C0920425 (UMLS CUI [1])
ecog
Item
5. performance status of 0, 1, 2 on the ecog criteria.
boolean
C1520224 (UMLS CUI [1])
response evaluation criteria in solid tumors
Item
6. at least one unidimensional measurable lesion meeting response evaluation criteria in solid tumors (recist. 2000).
boolean
C1709926 (UMLS CUI [1])
life expectancy
Item
7. estimated life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
follow-up compliance
Item
8. patient compliance that allow adequate follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
hematologic, hepatic, renal function
Item
9. adequate organ function including the following:adequate hematologic function: wbc count ≥ 3,500/ul, absolute neutrophil count (anc) ≥ 1,500/ul, and platelet count ≥ 100,000/uladequate hepatic function: bilirubin ≤ 1.5 x unl, alt or ast ≤ 2.5 x unl.adequate renal function: creatinine ≤ 1.5mg/dl.
boolean
C0221130 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C0948762 (UMLS CUI [1,3])
C0005821 (UMLS CUI [1,4])
C0232741 (UMLS CUI [2,1])
C1278039 (UMLS CUI [2,2])
C0201899 (UMLS CUI [2,3])
C0201836 (UMLS CUI [2,4])
C0232804 (UMLS CUI [3,1])
C0201976 (UMLS CUI [3,2])
informed consent
Item
10. informed consent from patient
boolean
C0021430 (UMLS CUI [1])
age
Item
11. males or females at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
effective contraception, pregnancy test
Item
12. if female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [iud], birth control pills, or barrier device) during and for 3 months after trial. if male, use of an approved contraceptive method during the study and 3 months afterwards. females with childbearing potential must have a urine negative hcg test within 7 days prior to the study registration.
boolean
C0700589 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
heart diseases
Item
1. mi within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
boolean
C0018799 (UMLS CUI [1])
infections
Item
2. serious concomitant infection including post obstructive pneumonia
boolean
C0009450 (UMLS CUI [1])
second primary malignancy
Item
3. second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
boolean
C0751623 (UMLS CUI [1])
pregnancy, breast feeding
Item
4. pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
psychiatric disorder, compliance
Item
5. psychiatric disorder that would preclude compliance.
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
major surgery
Item
6. major surgery other than biopsy within the past two weeks.
boolean
C0679637 (UMLS CUI [1])
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