ID

36647

Beschreibung

Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.; ODM derived from: https://clinicaltrials.gov/show/NCT02405910

Link

https://clinicaltrials.gov/show/NCT02405910

Stichworte

Versionen (1)
  1. 28.05.19 28.05.19 -
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See clinicaltrials.gov

Hochgeladen am

28. Mai 2019

DOI

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Eligibility Non-small Cell Lung Cancer NCT02405910

Englisch

Eligibility Non-small Cell Lung Cancer NCT02405910

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically proven newly diagnosed stage iv or stage iiib non-squamous non-small cell lung cancer (nsclc) - recurrent advanced nsclc will be allowed if they have never received chemotherapy for metastatic disease. - prior adjuvant chemotherapy will be allowed, if recurrence occurred ≥ 6 months after last treatment
Beschreibung

Non-squamous non-small cell lung cancer TNM clinical staging | Non-small cell lung cancer recurrent | Non-Small Cell Lung Carcinoma Advanced | Chemotherapy Absent Neoplasm Metastasis | Chemotherapy, Adjuvant | Recurrence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4324656
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0278517
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C0205179
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0027627
UMLS CUI [5]
C0085533
UMLS CUI [6]
C0034897
eastern cooperative oncology group (ecog) performance status 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
measurable disease as per response evaluation criteria in solid tumors (recist) 1.1
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
washout period of 4 weeks for chemo/radiation/experimental agents
Beschreibung

Washout Period Chemotherapy | Washout Period Therapeutic radiology procedure | Washout Period Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C1522449
UMLS CUI [3,1]
C1710661
UMLS CUI [3,2]
C0013230
resolution of all toxicities to < grade 2 prior to starting treatment (excluding alopecia)
Beschreibung

Toxicity resolution CTCAE Grades | Alopecia Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1514893
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0002170
UMLS CUI [2,2]
C0332196
patients must have < grade 2 pre-existing peripheral neuropathy (per ctcae)
Beschreibung

Peripheral Neuropathy Pre-existing CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
adequate hepatic, renal, and bone marrow functions
Beschreibung

Liver function | Renal function | Bone Marrow function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Beschreibung

Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
negative serum or urine β-hcg pregnancy test at screening for patients of childbearing potential
Beschreibung

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine beta hCG pregnancy test Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430056
UMLS CUI [2,3]
C1513916
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with new york heart association class iii or iv heart failure
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
women of child bearing potential (wocbp) are not currently pregnant or breast-feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma
Beschreibung

Second Primary Cancers | Exception Basal cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
previous anaphylactic or severe allergic reaction to paclitaxel and/or docetaxel will be excluded
Beschreibung

Anaphylaxis Paclitaxel | Allergic Reaction Severe Paclitaxel | Anaphylaxis Docetaxel | Allergic Reaction Severe Docetaxel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0144576
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0144576
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C0246415
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0246415
grade ≥2 peripheral neuropathy at baseline assessment from any cause
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
symptomatic brain metastases will be excluded. treated brain metastases will be allowed that are neurologically stable.
Beschreibung

Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Treated Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C0205360
patients with adenocarcinoma with activating egfr mutation (exon 19 deletions /
Beschreibung

Adenocarcinoma EGFR Activating Mutation EGFR exon 19 deletion | Adenocarcinoma EGFR Activating Mutation EGFR Exon 19 Insertion Mutation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C2984891
UMLS CUI [1,3]
C3889117
UMLS CUI [2,1]
C0001418
UMLS CUI [2,2]
C2984891
UMLS CUI [2,3]
C4525161
insertions, exon 21 point mutations) or eml4-alk translocation are excluded unless they are ineligible for epidermal growth factor receptor (egfr) or alk targeting agents.
Beschreibung

Adenocarcinoma EGFR Activating Mutation Point mutation in exon 21 | EML4 ALK Translocation | Exception Ineligibility Targeted Therapy EGFR | Exception Ineligibility Targeted Therapy ALK

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C2984891
UMLS CUI [1,3]
C3888903
UMLS CUI [2,1]
C1412993
UMLS CUI [2,2]
C1332080
UMLS CUI [2,3]
C0040715
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1512714
UMLS CUI [3,3]
C2985566
UMLS CUI [3,4]
C0034802
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1512714
UMLS CUI [4,3]
C2985566
UMLS CUI [4,4]
C1332080
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Beschreibung

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer NCT02405910

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-squamous non-small cell lung cancer TNM clinical staging | Non-small cell lung cancer recurrent | Non-Small Cell Lung Carcinoma Advanced | Chemotherapy Absent Neoplasm Metastasis | Chemotherapy, Adjuvant | Recurrence
Item
patients with histologically proven newly diagnosed stage iv or stage iiib non-squamous non-small cell lung cancer (nsclc) - recurrent advanced nsclc will be allowed if they have never received chemotherapy for metastatic disease. - prior adjuvant chemotherapy will be allowed, if recurrence occurred ≥ 6 months after last treatment
boolean
C4324656 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2])
C0007131 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
C0085533 (UMLS CUI [5])
C0034897 (UMLS CUI [6])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
measurable disease as per response evaluation criteria in solid tumors (recist) 1.1
boolean
C1513041 (UMLS CUI [1])
Washout Period Chemotherapy | Washout Period Therapeutic radiology procedure | Washout Period Investigational New Drugs
Item
washout period of 4 weeks for chemo/radiation/experimental agents
boolean
C1710661 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1710661 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1710661 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
Toxicity resolution CTCAE Grades | Alopecia Excluded
Item
resolution of all toxicities to < grade 2 prior to starting treatment (excluding alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0002170 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
patients must have < grade 2 pre-existing peripheral neuropathy (per ctcae)
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Liver function | Renal function | Bone Marrow function
Item
adequate hepatic, renal, and bone marrow functions
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods
Item
women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine beta hCG pregnancy test Negative
Item
negative serum or urine β-hcg pregnancy test at screening for patients of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Heart failure New York Heart Association Classification
Item
patient with new york heart association class iii or iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
women of child bearing potential (wocbp) are not currently pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Second Primary Cancers | Exception Basal cell carcinoma
Item
co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Anaphylaxis Paclitaxel | Allergic Reaction Severe Paclitaxel | Anaphylaxis Docetaxel | Allergic Reaction Severe Docetaxel
Item
previous anaphylactic or severe allergic reaction to paclitaxel and/or docetaxel will be excluded
boolean
C0002792 (UMLS CUI [1,1])
C0144576 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0144576 (UMLS CUI [2,3])
C0002792 (UMLS CUI [3,1])
C0246415 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0246415 (UMLS CUI [4,3])
Peripheral Neuropathy CTCAE Grades
Item
grade ≥2 peripheral neuropathy at baseline assessment from any cause
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Treated Stable
Item
symptomatic brain metastases will be excluded. treated brain metastases will be allowed that are neurologically stable.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Adenocarcinoma EGFR Activating Mutation EGFR exon 19 deletion | Adenocarcinoma EGFR Activating Mutation EGFR Exon 19 Insertion Mutation
Item
patients with adenocarcinoma with activating egfr mutation (exon 19 deletions /
boolean
C0001418 (UMLS CUI [1,1])
C2984891 (UMLS CUI [1,2])
C3889117 (UMLS CUI [1,3])
C0001418 (UMLS CUI [2,1])
C2984891 (UMLS CUI [2,2])
C4525161 (UMLS CUI [2,3])
Adenocarcinoma EGFR Activating Mutation Point mutation in exon 21 | EML4 ALK Translocation | Exception Ineligibility Targeted Therapy EGFR | Exception Ineligibility Targeted Therapy ALK
Item
insertions, exon 21 point mutations) or eml4-alk translocation are excluded unless they are ineligible for epidermal growth factor receptor (egfr) or alk targeting agents.
boolean
C0001418 (UMLS CUI [1,1])
C2984891 (UMLS CUI [1,2])
C3888903 (UMLS CUI [1,3])
C1412993 (UMLS CUI [2,1])
C1332080 (UMLS CUI [2,2])
C0040715 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1512714 (UMLS CUI [3,2])
C2985566 (UMLS CUI [3,3])
C0034802 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1512714 (UMLS CUI [4,2])
C2985566 (UMLS CUI [4,3])
C1332080 (UMLS CUI [4,4])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
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