ID

44321

Beschreibung

Pemetrexed in Advanced Non-Small-Cell Lung Cancer: at Progression vs Maintenance Therapy After Induction Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02004184

Link

https://clinicaltrials.gov/show/NCT02004184

Stichworte

Versionen (2)
  1. 17.10.19 17.10.19 -
  2. 20.09.21 20.09.21 -
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See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non-small-cell Lung NCT02004184

Englisch

Eligibility Carcinoma, Non-small-cell Lung NCT02004184

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
measureable disease according to the recist 1.1
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
previous radiotherapy is acceptable provided there are measurable, previously not irradiated lesions present
Beschreibung

Prior radiation therapy Acceptable | Prior radiation therapy Absent Measurable lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1513041
histologically or cytologically confirmed non-squamous non-small cell lung cancer
Beschreibung

Non-Squamous Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C4324656
stage iiib ineligible for curative therapy or stage iv disease
Beschreibung

Disease TNM clinical staging Ineligibility Curative treatment | Disease TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C1512714
UMLS CUI [1,4]
C1273390
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3258246
ecog performance 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function defined as:
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
1. serum aspartate transaminase (ast) and serum alanine transaminase (alt) ≤ 3 x upper limit of normal (uln), or ast and alt ≤ 5 x uln if liver function abnormalities are due to underlying malignancy.
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Liver Dysfunction Due to Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0086565
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0006826
2. total serum bilirubin ≤ 1.5 x uln
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
3. absolute neutrophil count (anc) ≥ 1.5 x 109/l
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
4. platelets ≥ 100 x 109/l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
5. creatinine clearance > 45 ml/min
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
able to discontinue nsaids and asa if reduced renal function
Beschreibung

Able Discontinue NSAIDs | Able Discontinue ASA | Renal function Reduced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0003211
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0004057
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0392756
all fertile patients should use safe contraception
Beschreibung

Patients Fertile Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0015895
UMLS CUI [1,3]
C0700589
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic therapy for advanced non-small-cell lung cancer (including egfr-tki). previous chemotherapy (e.g. adjuvant after surgery or for other cancer) is allowed if
Beschreibung

Systemic therapy Non-Small Cell Lung Carcinoma Advanced | EGFR-TKI | Exception Prior Chemotherapy | Exception Adjuvant Chemotherapy Post Surgery | Exception Adjuvant Chemotherapy Cancer Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205179
UMLS CUI [2]
C1443775
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1514457
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0085533
UMLS CUI [4,3]
C0687676
UMLS CUI [4,4]
C0543467
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0085533
UMLS CUI [5,3]
C1707251
≥ 3 months since the last course was administered.
Beschreibung

ID.16

Datentyp

boolean

activating egfr-mutation or alk-translocation detected
Beschreibung

EGFR Activating Mutation | ALK Translocation

Datentyp

boolean

Alias
UMLS CUI [1]
C2984891
UMLS CUI [2]
C4329227
serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
Beschreibung

Comorbidity Serious Systemic | Communicable Disease | Cardiovascular Disease Unstable | Comorbidity compromises Completion of clinical trial | Comorbidity Interferes with Evaluation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205373
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C2732579
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1261322
conditions - medical, social, psychological - which could prevent adequate information and follow-up
Beschreibung

Medical condition Preventing Information | Social situation Preventing Information | Mental condition Preventing Information | Medical condition Preventing Follow-up | Social situation Preventing Follow-up | Mental condition Preventing Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1533716
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1533716
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C1533716
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C3274571
UMLS CUI [5,1]
C0748872
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C3274571
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C3274571
clinically active cancer other than nsclc
Beschreibung

Malignant Neoplasms | Exception Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007131
known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, b12, folate)
Beschreibung

Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs | Hypersensitivity Vinorelbine | Medical contraindication Vinorelbine | Carboplatin allergy | Medical contraindication Carboplatin | Hypersensitivity Pemetrexed | Medical contraindication Pemetrexed | Vitamin B12 preparation allergy | Medical contraindication Vitamin B 12 | Hypersensitivity Folate | Medical contraindication Folate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0078257
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0078257
UMLS CUI [5]
C0570701
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0079083
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0210657
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0210657
UMLS CUI [9]
C0571836
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C0042845
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0178638
UMLS CUI [12,1]
C1301624
UMLS CUI [12,2]
C0178638
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Carcinoma, Non-small-cell Lung NCT02004184

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Measurable Disease
Item
measureable disease according to the recist 1.1
boolean
C1513041 (UMLS CUI [1])
Prior radiation therapy Acceptable | Prior radiation therapy Absent Measurable lesion
Item
previous radiotherapy is acceptable provided there are measurable, previously not irradiated lesions present
boolean
C0279134 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
Non-Squamous Non-Small Cell Lung Carcinoma
Item
histologically or cytologically confirmed non-squamous non-small cell lung cancer
boolean
C4324656 (UMLS CUI [1])
Disease TNM clinical staging Ineligibility Curative treatment | Disease TNM clinical staging
Item
stage iiib ineligible for curative therapy or stage iv disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C1273390 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance 0-2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function defined as:
boolean
C0678852 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Liver Dysfunction Due to Malignant Neoplasms
Item
1. serum aspartate transaminase (ast) and serum alanine transaminase (alt) ≤ 3 x upper limit of normal (uln), or ast and alt ≤ 5 x uln if liver function abnormalities are due to underlying malignancy.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0086565 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
Serum total bilirubin measurement
Item
2. total serum bilirubin ≤ 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Absolute neutrophil count
Item
3. absolute neutrophil count (anc) ≥ 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
4. platelets ≥ 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Creatinine clearance measurement
Item
5. creatinine clearance > 45 ml/min
boolean
C0373595 (UMLS CUI [1])
Able Discontinue NSAIDs | Able Discontinue ASA | Renal function Reduced
Item
able to discontinue nsaids and asa if reduced renal function
boolean
C0085732 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0004057 (UMLS CUI [2,3])
C0232804 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
Patients Fertile Contraceptive methods
Item
all fertile patients should use safe contraception
boolean
C0030705 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Non-Small Cell Lung Carcinoma Advanced | EGFR-TKI | Exception Prior Chemotherapy | Exception Adjuvant Chemotherapy Post Surgery | Exception Adjuvant Chemotherapy Cancer Other
Item
prior systemic therapy for advanced non-small-cell lung cancer (including egfr-tki). previous chemotherapy (e.g. adjuvant after surgery or for other cancer) is allowed if
boolean
C1515119 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1443775 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1514457 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0085533 (UMLS CUI [4,2])
C0687676 (UMLS CUI [4,3])
C0543467 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0085533 (UMLS CUI [5,2])
C1707251 (UMLS CUI [5,3])
ID.16
Item
≥ 3 months since the last course was administered.
boolean
EGFR Activating Mutation | ALK Translocation
Item
activating egfr-mutation or alk-translocation detected
boolean
C2984891 (UMLS CUI [1])
C4329227 (UMLS CUI [2])
Comorbidity Serious Systemic | Communicable Disease | Cardiovascular Disease Unstable | Comorbidity compromises Completion of clinical trial | Comorbidity Interferes with Evaluation
Item
serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2])
C0007222 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0009488 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
C0009488 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
Medical condition Preventing Information | Social situation Preventing Information | Mental condition Preventing Information | Medical condition Preventing Follow-up | Social situation Preventing Follow-up | Mental condition Preventing Follow-up
Item
conditions - medical, social, psychological - which could prevent adequate information and follow-up
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1533716 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C1533716 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
Malignant Neoplasms | Exception Non-Small Cell Lung Carcinoma
Item
clinically active cancer other than nsclc
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs | Hypersensitivity Vinorelbine | Medical contraindication Vinorelbine | Carboplatin allergy | Medical contraindication Carboplatin | Hypersensitivity Pemetrexed | Medical contraindication Pemetrexed | Vitamin B12 preparation allergy | Medical contraindication Vitamin B 12 | Hypersensitivity Folate | Medical contraindication Folate
Item
known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, b12, folate)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0078257 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0078257 (UMLS CUI [4,2])
C0570701 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0079083 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0210657 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0210657 (UMLS CUI [8,2])
C0571836 (UMLS CUI [9])
C1301624 (UMLS CUI [10,1])
C0042845 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0178638 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C0178638 (UMLS CUI [12,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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