ID

41184

Descrizione

ERCC1 Targeted Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00801736

collegamento

https://clinicaltrials.gov/show/NCT00801736

Keywords

versioni (1)
  1. 07/07/20 07/07/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

7 luglio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 4.0
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Eligibility Lung Cancer NCT00801736

Inglese

Eligibility Lung Cancer NCT00801736

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological confirmation of non-squamous nsclc
Descrizione

Non-squamous non-small cell lung cancer

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4324656
2. have a tissue biopsy available for sending to the central laboratory to determine ercc1 status
Descrizione

Availability of Biopsy tissue | Determination ERCC1 Status

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C3864006
UMLS CUI [2,1]
C0521095
UMLS CUI [2,2]
C1333355
UMLS CUI [2,3]
C0449438
3. presentation with stage iiib (not amenable to curative treatment) or iv disease -
Descrizione

Disease TNM clinical staging | Disease Inappropriate Curative treatment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1273390
staging scans must be no more than 28 days prior to registration. patients with relapsed nsclc must not have received prior chemotherapy or biological therapy (previous surgery or radical radiotherapy allowed)
Descrizione

TNM clinical staging Recent | Non-small cell lung cancer recurrent Prior Chemotherapy Absent | Non-small cell lung cancer recurrent Biological treatment Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0278517
UMLS CUI [2,2]
C1514457
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0278517
UMLS CUI [3,2]
C1531518
UMLS CUI [3,3]
C0332197
4. at least one measurable lesion according to response evaluation criteria in solid tumours
Descrizione

Measurable lesion Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
5. either sex, at least 18 years of age
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
6. ecog performance status 0-1
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
7. estimated life expectancy of at least 8 weeks
Descrizione

Life Expectancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023671
8. adequate bone marrow function as evidenced by the following (assessed within 14 days of registration):
Descrizione

Bone Marrow function

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
absolute neutrophil count (anc) ≥1.5 × 109/l
Descrizione

Absolute neutrophil count

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥100 × 109/l
Descrizione

Platelet Count measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032181
haemoglobin ≥9 g/dl
Descrizione

Hemoglobin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0518015
9. adequate liver function as evidenced by the following (assessed within 14 days of registration):
Descrizione

Liver function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
total bilirubin ≤ 1.5 x upper limit of normal (uln)
Descrizione

Serum total bilirubin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1278039
aspartate transaminase (ast) ≤3 × uln or ≤5 × uln is acceptable with liver metastases
Descrizione

Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0494165
alanine transaminase (alt) ≤3 × uln
Descrizione

Alanine aminotransferase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201836
10. adequate renal function as evidenced by the following (assessed within 14 days of registration):
Descrizione

Renal function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232804
gfr > 60ml/min as measured by creatinine clearance through edta. alternatively, the cockcroft and gault formula may be used to estimate gfr, but if < 60 ml/min then edta should be performed.
Descrizione

Glomerular Filtration Rate | Creatinine clearance measurement EDTA | Glomerular Filtration Rate Cockcroft-Gault formula

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2,1]
C0373595
UMLS CUI [2,2]
C0013618
UMLS CUI [3,1]
C0017654
UMLS CUI [3,2]
C2924627
11. previous palliative radiotherapy to non-target metastatic lesions is allowed for pain relief prior to starting chemotherapy
Descrizione

Palliative course of radiotherapy Metastatic Lesion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C1513183
12. patients with stable brain metastases will be allowed to enrol. stable brain metastases being defined as no progression of brain metastases 28 days after treatment as documented by a ct scan/mri of the brain. patients with incidentally discovered asymptomatic brain metastases may be enrolled and treated with trial chemotherapy without prior brain irradiation if deemed feasible by the treating physician
Descrizione

Metastatic malignant neoplasm to brain Stable | Disease Progression Absent CT scan | Disease Progression Absent MRI

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0024485
13. signed informed consent form
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
14. use of effective contraception during, and for 6 months after trial treatment by patients of reproductive potential and partners of reproductive potential. patients who receive aprepitant (anti-emetic) must be willing to use an alternative or back-up method to hormonal contraceptives as aprepitant may reduce their efficacy. female patients with childbearing potential must have a negative serum pregnancy test prior to registration.
Descrizione

Females & males of reproductive potential Contraceptive methods | Partner Reproductive potential Contraceptive methods | Aprepitant Contraceptive methods Alternative | Childbearing Potential Serum pregnancy test negative

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C4034483
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C1176306
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1523987
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430061
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. cytologically or clinically diagnosed nsclc
Descrizione

Non-Small Cell Lung Carcinoma Cytology

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0010818
2. evidence of significant medical condition or laboratory finding which, in the opinion of the treating physician or chief investigator, makes it undesirable for the patient to participate in the trial
Descrizione

Medical condition Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
3. presence of uncontrolled brain or leptomeningeal metastases thought to require immediate radiotherapy
Descrizione

Metastatic malignant neoplasm to brain Uncontrolled | Metastatic Malignant Neoplasm to the Leptomeninges Uncontrolled | Therapeutic radiology procedure Required

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C1514873
4. presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to trial entry
Descrizione

Body Fluids Space Third | Ascites | Pleural effusion | Control Unsuccessful

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005889
UMLS CUI [1,2]
C1883067
UMLS CUI [1,3]
C0205437
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0032227
UMLS CUI [4,1]
C2587213
UMLS CUI [4,2]
C1272705
5. yellow fever vaccination received within the 30 days previous to study entry
Descrizione

Vaccination against yellow fever

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0199823
6. unable to interrupt aspirin or other nsaids (for pemetrexed arms of the trial)
Descrizione

Aspirin Discontinue Unable | NSAIDs Discontinue Unable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1299582
7. unable or unwilling to take vitamin b12 and folic acid (for pemetrexed arms of the trial)
Descrizione

Intake Vitamin B12 Unable | Intake Folic acid Unable | Intake Vitamin B12 Unwilling | Intake Folic acid Unwilling

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0042845
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0016410
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C1512806
UMLS CUI [3,2]
C0042845
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C1512806
UMLS CUI [4,2]
C0016410
UMLS CUI [4,3]
C0558080
8. a history of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer
Descrizione

Malignant Neoplasm | Exception Disease Free Duration | Exception Skin carcinoma | Exception Cervical cancer Early

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C4048328
UMLS CUI [4,3]
C1279919
9. pregnant or lactating women
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. inability to comply with protocol or trial procedures
Descrizione

Protocol Compliance Unable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Lung Cancer NCT00801736

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Non-squamous non-small cell lung cancer
Item
1. histological confirmation of non-squamous nsclc
boolean
C4324656 (UMLS CUI [1])
Availability of Biopsy tissue | Determination ERCC1 Status
Item
2. have a tissue biopsy available for sending to the central laboratory to determine ercc1 status
boolean
C0470187 (UMLS CUI [1,1])
C3864006 (UMLS CUI [1,2])
C0521095 (UMLS CUI [2,1])
C1333355 (UMLS CUI [2,2])
C0449438 (UMLS CUI [2,3])
Disease TNM clinical staging | Disease Inappropriate Curative treatment
Item
3. presentation with stage iiib (not amenable to curative treatment) or iv disease -
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1273390 (UMLS CUI [2,3])
TNM clinical staging Recent | Non-small cell lung cancer recurrent Prior Chemotherapy Absent | Non-small cell lung cancer recurrent Biological treatment Absent
Item
staging scans must be no more than 28 days prior to registration. patients with relapsed nsclc must not have received prior chemotherapy or biological therapy (previous surgery or radical radiotherapy allowed)
boolean
C3258246 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0278517 (UMLS CUI [3,1])
C1531518 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Measurable lesion Quantity
Item
4. at least one measurable lesion according to response evaluation criteria in solid tumours
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Age
Item
5. either sex, at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
6. ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. estimated life expectancy of at least 8 weeks
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function
Item
8. adequate bone marrow function as evidenced by the following (assessed within 14 days of registration):
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥1.5 × 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥100 × 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin ≥9 g/dl
boolean
C0518015 (UMLS CUI [1])
Liver function
Item
9. adequate liver function as evidenced by the following (assessed within 14 days of registration):
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤ 1.5 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
aspartate transaminase (ast) ≤3 × uln or ≤5 × uln is acceptable with liver metastases
boolean
C0201899 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Alanine aminotransferase measurement
Item
alanine transaminase (alt) ≤3 × uln
boolean
C0201836 (UMLS CUI [1])
Renal function
Item
10. adequate renal function as evidenced by the following (assessed within 14 days of registration):
boolean
C0232804 (UMLS CUI [1])
Glomerular Filtration Rate | Creatinine clearance measurement EDTA | Glomerular Filtration Rate Cockcroft-Gault formula
Item
gfr > 60ml/min as measured by creatinine clearance through edta. alternatively, the cockcroft and gault formula may be used to estimate gfr, but if < 60 ml/min then edta should be performed.
boolean
C0017654 (UMLS CUI [1])
C0373595 (UMLS CUI [2,1])
C0013618 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3,1])
C2924627 (UMLS CUI [3,2])
Palliative course of radiotherapy Metastatic Lesion
Item
11. previous palliative radiotherapy to non-target metastatic lesions is allowed for pain relief prior to starting chemotherapy
boolean
C0475092 (UMLS CUI [1,1])
C1513183 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Stable | Disease Progression Absent CT scan | Disease Progression Absent MRI
Item
12. patients with stable brain metastases will be allowed to enrol. stable brain metastases being defined as no progression of brain metastases 28 days after treatment as documented by a ct scan/mri of the brain. patients with incidentally discovered asymptomatic brain metastases may be enrolled and treated with trial chemotherapy without prior brain irradiation if deemed feasible by the treating physician
boolean
C0220650 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
Informed Consent
Item
13. signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods | Partner Reproductive potential Contraceptive methods | Aprepitant Contraceptive methods Alternative | Childbearing Potential Serum pregnancy test negative
Item
14. use of effective contraception during, and for 6 months after trial treatment by patients of reproductive potential and partners of reproductive potential. patients who receive aprepitant (anti-emetic) must be willing to use an alternative or back-up method to hormonal contraceptives as aprepitant may reduce their efficacy. female patients with childbearing potential must have a negative serum pregnancy test prior to registration.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C4034483 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1176306 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1523987 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0430061 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Non-Small Cell Lung Carcinoma Cytology
Item
1. cytologically or clinically diagnosed nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0010818 (UMLS CUI [1,2])
Medical condition Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
2. evidence of significant medical condition or laboratory finding which, in the opinion of the treating physician or chief investigator, makes it undesirable for the patient to participate in the trial
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Metastatic malignant neoplasm to brain Uncontrolled | Metastatic Malignant Neoplasm to the Leptomeninges Uncontrolled | Therapeutic radiology procedure Required
Item
3. presence of uncontrolled brain or leptomeningeal metastases thought to require immediate radiotherapy
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Body Fluids Space Third | Ascites | Pleural effusion | Control Unsuccessful
Item
4. presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to trial entry
boolean
C0005889 (UMLS CUI [1,1])
C1883067 (UMLS CUI [1,2])
C0205437 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2])
C0032227 (UMLS CUI [3])
C2587213 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
Vaccination against yellow fever
Item
5. yellow fever vaccination received within the 30 days previous to study entry
boolean
C0199823 (UMLS CUI [1])
Aspirin Discontinue Unable | NSAIDs Discontinue Unable
Item
6. unable to interrupt aspirin or other nsaids (for pemetrexed arms of the trial)
boolean
C0004057 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Intake Vitamin B12 Unable | Intake Folic acid Unable | Intake Vitamin B12 Unwilling | Intake Folic acid Unwilling
Item
7. unable or unwilling to take vitamin b12 and folic acid (for pemetrexed arms of the trial)
boolean
C1512806 (UMLS CUI [1,1])
C0042845 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1512806 (UMLS CUI [2,1])
C0016410 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C1512806 (UMLS CUI [3,1])
C0042845 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C1512806 (UMLS CUI [4,1])
C0016410 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Malignant Neoplasm | Exception Disease Free Duration | Exception Skin carcinoma | Exception Cervical cancer Early
Item
8. a history of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C4048328 (UMLS CUI [4,2])
C1279919 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
9. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Protocol Compliance Unable
Item
10. inability to comply with protocol or trial procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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