ID

31210

Beschreibung

Pemetrexed Followed by Docetaxel or in Reverse Sequence; ODM derived from: https://clinicaltrials.gov/show/NCT01442909

Link

https://clinicaltrials.gov/show/NCT01442909

Stichworte

Versionen (1)
  1. 29.07.18 29.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Juli 2018

DOI

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Lizenz

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Eligibility Non-small-cell Lung Cancer NCT01442909

Englisch

Eligibility Non-small-cell Lung Cancer NCT01442909

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed non-small cell bronchogenic carcinoma, inoperable stage iiib or iv
Beschreibung

Bronchogenic Carcinoma Non-small cell Inoperable TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007121
UMLS CUI [1,2]
C0445128
UMLS CUI [1,3]
C0205187
UMLS CUI [1,4]
C3258246
2. aged 18 years or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. failed previous platinum-based chemotherapy
Beschreibung

Prior Chemotherapy Platinum-Based failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C0231175
4. presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥ 20 mm with conventional ct or ≥ 10 mm with spiral ct scan
Beschreibung

Measurable Disease Quantity | Measurable lesion Dimension Quantity CT | Measurable lesion Dimension Quantity Spiral CT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0040405
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0439534
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0860888
5. performance status of eastern cooperative oncology group (ecog) 0, 1, or 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. white blood cell (wbc) ≥ 3,000/mm3, absolute neutrophil count (anc) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 10 mg / dl
Beschreibung

White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
7. serum creatinine level 2.0 mg/dl or lower
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
8. serum bilirubin less than 1.5 times the upper limit of normal range (uln)
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
9. alanine aminotransferase (alt) or aspartate aminotransferase (ast) less than 3 times the uln (less than 5 times the uln in liver metastases)
Beschreibung

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Relationship Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
10. written informed consent to participate in the trial in addition, in female patient with childbearing potential, either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [iud], birth control pills, or barrier device) during and for three months after trial. patients who previously treated by surgery are needed to demonstrate progressive disease before entering the study.
Beschreibung

Informed Consent | Childbearing Potential Contraceptive methods | Female Sterilization | Radiation | Menopause | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier | Operative Surgical Procedures Previous | Progressive Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0015787
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0025320
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0004764
UMLS CUI [9,1]
C0543467
UMLS CUI [9,2]
C0205156
UMLS CUI [10]
C1335499
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active infection (at the discretion of the investigator).
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
2. active central nervous system (cns) metastases.
Beschreibung

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
3. breast feeding.
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
4. serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
Beschreibung

Comorbidity Systemic Serious | Comorbidity Inconsistent Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0442809
UMLS CUI [2,3]
C0008976
5. use of any investigational agent in the month before enrollment into the study.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
6. concomitant myelosuppressive radiotherapy to target lesion, chemotherapy, hormonal therapy, or immunotherapy will not be allowed.
Beschreibung

Therapeutic radiology procedure Myelosuppressive Target Lesion | Chemotherapy | Hormone Therapy | Immunotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1513793
UMLS CUI [1,3]
C2986546
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
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Ähnliche Modelle

Eligibility Non-small-cell Lung Cancer NCT01442909

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Bronchogenic Carcinoma Non-small cell Inoperable TNM clinical staging
Item
1. histologically or cytologically confirmed non-small cell bronchogenic carcinoma, inoperable stage iiib or iv
boolean
C0007121 (UMLS CUI [1,1])
C0445128 (UMLS CUI [1,2])
C0205187 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Age
Item
2. aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Prior Chemotherapy Platinum-Based failed
Item
3. failed previous platinum-based chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Measurable Disease Quantity | Measurable lesion Dimension Quantity CT | Measurable lesion Dimension Quantity Spiral CT
Item
4. presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥ 20 mm with conventional ct or ≥ 10 mm with spiral ct scan
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
C1513041 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0860888 (UMLS CUI [3,4])
ECOG performance status
Item
5. performance status of eastern cooperative oncology group (ecog) 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
6. white blood cell (wbc) ≥ 3,000/mm3, absolute neutrophil count (anc) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 10 mg / dl
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Creatinine measurement, serum
Item
7. serum creatinine level 2.0 mg/dl or lower
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
8. serum bilirubin less than 1.5 times the upper limit of normal range (uln)
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
9. alanine aminotransferase (alt) or aspartate aminotransferase (ast) less than 3 times the uln (less than 5 times the uln in liver metastases)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Informed Consent | Childbearing Potential Contraceptive methods | Female Sterilization | Radiation | Menopause | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier | Operative Surgical Procedures Previous | Progressive Disease
Item
10. written informed consent to participate in the trial in addition, in female patient with childbearing potential, either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [iud], birth control pills, or barrier device) during and for three months after trial. patients who previously treated by surgery are needed to demonstrate progressive disease before entering the study.
boolean
C0021430 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0025320 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
C0543467 (UMLS CUI [9,1])
C0205156 (UMLS CUI [9,2])
C1335499 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
1. active infection (at the discretion of the investigator).
boolean
C0009450 (UMLS CUI [1])
CNS metastases
Item
2. active central nervous system (cns) metastases.
boolean
C0686377 (UMLS CUI [1])
Breast Feeding
Item
3. breast feeding.
boolean
C0006147 (UMLS CUI [1])
Comorbidity Systemic Serious | Comorbidity Inconsistent Clinical Trial
Item
4. serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
boolean
C0009488 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0442809 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Investigational New Drugs
Item
5. use of any investigational agent in the month before enrollment into the study.
boolean
C0013230 (UMLS CUI [1])
Therapeutic radiology procedure Myelosuppressive Target Lesion | Chemotherapy | Hormone Therapy | Immunotherapy
Item
6. concomitant myelosuppressive radiotherapy to target lesion, chemotherapy, hormonal therapy, or immunotherapy will not be allowed.
boolean
C1522449 (UMLS CUI [1,1])
C1513793 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
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