ID

31063

Beschreibung

Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01196234

Link

https://clinicaltrials.gov/show/NCT01196234

Stichworte

Versionen (1)
  1. 16.07.18 16.07.18 -
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See clinicaltrials.gov

Hochgeladen am

16. Juli 2018

DOI

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Eligibility Non Small Cell Lung Cancer NCT01196234

Englisch

Eligibility Non Small Cell Lung Cancer NCT01196234

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
more than 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically documented non-small cell lung cancer with metastasis (stage iv) or locally advanced (stage iiib) with malignant effusion.
Beschreibung

Non-small cell lung cancer metastatic TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Effusion Malignant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278987
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [2,4]
C3258246
UMLS CUI [3,1]
C0013687
UMLS CUI [3,2]
C0205282
at least 1 measurable lesion as defined by recist1.0. all target lesions must have a unidirectional diameter of at least 1cm. baseline measurements must be compared within 4 weeks prior to enrollment.
Beschreibung

Measurable lesion Quantity | Target Lesion Diameter Linear

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0205132
ecog ps 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
at least 1 week since the last radiotherapy. patients must have recovered from all acute toxicities from radiotherapy.
Beschreibung

Therapeutic radiology procedure In the past | Toxicity Due to Therapeutic radiology procedure | Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1522449
UMLS CUI [3]
C1115804
patients must have adequate hematologic, renal and liver function as defined by hb > 9g/dl, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dl, and ast (sgot) and/or alt (sgpt) < 5 x unl (upper normal limit).
Beschreibung

Hematologic function | Renal function | Liver function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0200633
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0201976
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0201836
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
written and voluntary informed consent understood, signed and dated.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with tumor harboring egfr mutation.
Beschreibung

Tumor Associated with EGFR gene mutation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C3266992
prior systemic therapy for nsclc
Beschreibung

Systemic therapy Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0007131
non-smoking patients with adenocarcinoma. but if those patients show wild type egfr, they are eligible to this study.
Beschreibung

Non-smoker | Adenocarcinoma | Patients EGFR gene Wild Type Eligible

Datentyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0001418
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1414313
UMLS CUI [3,3]
C1883559
UMLS CUI [3,4]
C1548635
symptomatic brain metastasis. brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
Beschreibung

Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Stable | Metastatic malignant neoplasm to brain Requirement Steroid therapy | Metastatic malignant neoplasm to brain Symptoms Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0149783
UMLS CUI [4,1]
C0220650
UMLS CUI [4,2]
C1457887
UMLS CUI [4,3]
C0205210
major surgery within 3 weeks prior to study enrollment.
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
Beschreibung

Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0553723
severe medical illness or active infection that would impair the ability to receive gefitinib.
Beschreibung

Illness Severe | Communicable Disease | Gefitinib Receive Impaired

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C1122962
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C0221099
pregnancy or breast feeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Eligibility Non Small Cell Lung Cancer NCT01196234

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
more than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Non-small cell lung cancer metastatic TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Effusion Malignant
Item
histologically documented non-small cell lung cancer with metastasis (stage iv) or locally advanced (stage iiib) with malignant effusion.
boolean
C0278987 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C0013687 (UMLS CUI [3,1])
C0205282 (UMLS CUI [3,2])
Measurable lesion Quantity | Target Lesion Diameter Linear
Item
at least 1 measurable lesion as defined by recist1.0. all target lesions must have a unidirectional diameter of at least 1cm. baseline measurements must be compared within 4 weeks prior to enrollment.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0205132 (UMLS CUI [2,3])
ECOG performance status
Item
ecog ps 0-2
boolean
C1520224 (UMLS CUI [1])
Therapeutic radiology procedure In the past | Toxicity Due to Therapeutic radiology procedure | Patient recovered
Item
at least 1 week since the last radiotherapy. patients must have recovered from all acute toxicities from radiotherapy.
boolean
C1522449 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
Hematologic function | Renal function | Liver function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
patients must have adequate hematologic, renal and liver function as defined by hb > 9g/dl, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dl, and ast (sgot) and/or alt (sgpt) < 5 x unl (upper normal limit).
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
Protocol Compliance
Item
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
written and voluntary informed consent understood, signed and dated.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor Associated with EGFR gene mutation
Item
patients with tumor harboring egfr mutation.
boolean
C0027651 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C3266992 (UMLS CUI [1,3])
Systemic therapy Non-Small Cell Lung Carcinoma
Item
prior systemic therapy for nsclc
boolean
C1515119 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
Non-smoker | Adenocarcinoma | Patients EGFR gene Wild Type Eligible
Item
non-smoking patients with adenocarcinoma. but if those patients show wild type egfr, they are eligible to this study.
boolean
C0337672 (UMLS CUI [1])
C0001418 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C1414313 (UMLS CUI [3,2])
C1883559 (UMLS CUI [3,3])
C1548635 (UMLS CUI [3,4])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Stable | Metastatic malignant neoplasm to brain Requirement Steroid therapy | Metastatic malignant neoplasm to brain Symptoms Clinical
Item
symptomatic brain metastasis. brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0149783 (UMLS CUI [3,3])
C0220650 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C0205210 (UMLS CUI [4,3])
Major surgery
Item
major surgery within 3 weeks prior to study enrollment.
boolean
C0679637 (UMLS CUI [1])
Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin
Item
previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0553723 (UMLS CUI [4,3])
Illness Severe | Communicable Disease | Gefitinib Receive Impaired
Item
severe medical illness or active infection that would impair the ability to receive gefitinib.
boolean
C0221423 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C1122962 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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