ID

39177

Beschreibung

Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01752205

Link

https://clinicaltrials.gov/show/NCT01752205

Stichworte

Versionen (1)
  1. 08.12.19 08.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Dezember 2019

DOI

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Lizenz

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Eligibility Esophageal Squamous Carcinoma NCT01752205

Englisch

Eligibility Esophageal Squamous Carcinoma NCT01752205

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed squamous cell carcinoma of esophagus or esophagogastric junction
Beschreibung

Squamous cell carcinoma of esophagus | Esophagogastric Junction

Datentyp

boolean

Alias
UMLS CUI [1]
C0279626
UMLS CUI [2]
C0014871
2. age >= 18
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. ecog ps 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
4. ineligibility for surgery
Beschreibung

Ineligibility Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0543467
5. no prior palliative therapy
Beschreibung

Palliative therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030231
UMLS CUI [1,2]
C0332197
6. at least one bidimensionally measurable disease as defined by recist ver 1.1
Beschreibung

Measurable Disease 2-Dimensional Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
7. adequate organ function for treatment
Beschreibung

Organ function Adequate Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C0087111
absolute neutrophil count (anc)>=1000cells/mm3
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets >=100000 cells/mm3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
estimated creatinine clearance>=50ml/min, or serum creatinine<1.5 x institution upper limit of normal
Beschreibung

Creatinine clearance measurement Estimated | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0373595
UMLS CUI [1,2]
C0750572
UMLS CUI [2]
C0201976
bilirubin=<1.5 x upper limit of normal(uln)
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
ast(sgot)=<2.5 x uln (5.0xuln if hepatic metastases)
Beschreibung

Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0494165
alt(sgpt)=<2.5 x uln (5.0xuln if hepatic metastases)
Beschreibung

Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0494165
12-lead electrocardiogram(ecg) with normal tracing or non-clinically significant changes that do not require medical intervention
Beschreibung

12 lead ECG Normal | 12 lead ECG Change | Requirement Absent Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C0392747
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0184661
qtc interval =<470 msec and without history of torsades de points or other symptomatic qtc abnormality
Beschreibung

QTc | Torsades de Pointes Absent | QTc Abnormality Symptomatic Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0860814
UMLS CUI [2,1]
C0040479
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0860814
UMLS CUI [3,2]
C1704258
UMLS CUI [3,3]
C0231220
UMLS CUI [3,4]
C0332197
lvef (by muga or echocardiogram) of >=50%.
Beschreibung

Left ventricular ejection fraction MUGA | Left ventricular ejection fraction Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
8. the patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous treatment with small molecule egfr tyrosine kinase inhibitors
Beschreibung

Small Molecule EGFR Tyrosine Kinase inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1328819
UMLS CUI [1,2]
C1443775
2. any major operation within 4 weeks of baseline disease assessment
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
3. any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
Beschreibung

Abnormality of the gastrointestinal tract Impairing Intake Investigational New Drug | Abnormality of the gastrointestinal tract Impairing Absorption Investigational New Drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4023588
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C1512806
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C4023588
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
4. cns metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
Beschreibung

CNS metastases | Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0001617
5. patients with known interstitial lung disease
Beschreibung

Lung Disease, Interstitial

Datentyp

boolean

Alias
UMLS CUI [1]
C0206062
6. patients with uncontrolled or significant cardiovascular disease (ami within 12 months,unstable angina within 6 months, nyha class iii, iv congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, congenital long qt syndrome, any significant ventricular arrhythmia, any uncontrolled second or third degree heart block, uncontrolled hypertension)
Beschreibung

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant | Acute myocardial infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction low | Congenital long QT syndrome | Ventricular arrhythmia | Second degree atrioventricular block Uncontrolled | Complete atrioventricular block Uncontrolled | Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0155626
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0428772
UMLS CUI [6,2]
C0205251
UMLS CUI [7]
C1141890
UMLS CUI [8]
C0085612
UMLS CUI [9,1]
C0264906
UMLS CUI [9,2]
C0205318
UMLS CUI [10,1]
C0151517
UMLS CUI [10,2]
C0205318
UMLS CUI [11]
C1868885
7. previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry.
Beschreibung

Malignant Neoplasm Previous | Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Curative treatment Solid Neoplasm | Exception Recurrence Free Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1273390
UMLS CUI [6,3]
C0280100
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0034897
UMLS CUI [7,3]
C0332296
UMLS CUI [7,4]
C0449238
8. pregnant or breast-feeding women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
Beschreibung

Other medical condition Severe Study Subject Participation Status At risk | Other medical condition chronic Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Other medical condition Severe Investigational New Drugs At risk | Other medical condition chronic Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Other medical condition Severe Interferes with Research results | Other medical condition chronic Interferes with Research results | Laboratory test result abnormal Interferes with Research results | Other medical condition Severe Study Subject Participation Status Inappropriate | Other medical condition chronic Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1444641
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0013230
UMLS CUI [4,4]
C1444641
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0205191
UMLS CUI [5,3]
C0013230
UMLS CUI [5,4]
C1444641
UMLS CUI [6,1]
C0438215
UMLS CUI [6,2]
C0013230
UMLS CUI [6,3]
C1444641
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C0521102
UMLS CUI [7,4]
C0683954
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0205191
UMLS CUI [8,3]
C0521102
UMLS CUI [8,4]
C0683954
UMLS CUI [9,1]
C0438215
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0683954
UMLS CUI [10,1]
C3843040
UMLS CUI [10,2]
C0205082
UMLS CUI [10,3]
C2348568
UMLS CUI [10,4]
C1548788
UMLS CUI [11,1]
C3843040
UMLS CUI [11,2]
C0205191
UMLS CUI [11,3]
C2348568
UMLS CUI [11,4]
C1548788
UMLS CUI [12,1]
C0438215
UMLS CUI [12,2]
C2348568
UMLS CUI [12,3]
C1548788
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Ähnliche Modelle

Eligibility Esophageal Squamous Carcinoma NCT01752205

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus | Esophagogastric Junction
Item
1. histologically confirmed squamous cell carcinoma of esophagus or esophagogastric junction
boolean
C0279626 (UMLS CUI [1])
C0014871 (UMLS CUI [2])
Age
Item
2. age >= 18
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog ps 0-2
boolean
C1520224 (UMLS CUI [1])
Ineligibility Operative Surgical Procedures
Item
4. ineligibility for surgery
boolean
C1512714 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Palliative therapy Absent
Item
5. no prior palliative therapy
boolean
C0030231 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable Disease 2-Dimensional Quantity
Item
6. at least one bidimensionally measurable disease as defined by recist ver 1.1
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Organ function Adequate Treatment
Item
7. adequate organ function for treatment
boolean
C0678852 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Absolute neutrophil count
Item
absolute neutrophil count (anc)>=1000cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >=100000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Creatinine clearance measurement Estimated | Creatinine measurement, serum
Item
estimated creatinine clearance>=50ml/min, or serum creatinine<1.5 x institution upper limit of normal
boolean
C0373595 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin=<1.5 x upper limit of normal(uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
ast(sgot)=<2.5 x uln (5.0xuln if hepatic metastases)
boolean
C0201899 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
alt(sgpt)=<2.5 x uln (5.0xuln if hepatic metastases)
boolean
C0201836 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
12 lead ECG Normal | 12 lead ECG Change | Requirement Absent Intervention
Item
12-lead electrocardiogram(ecg) with normal tracing or non-clinically significant changes that do not require medical intervention
boolean
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0430456 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0184661 (UMLS CUI [3,3])
QTc | Torsades de Pointes Absent | QTc Abnormality Symptomatic Absent
Item
qtc interval =<470 msec and without history of torsades de points or other symptomatic qtc abnormality
boolean
C0860814 (UMLS CUI [1])
C0040479 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0860814 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0231220 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
Left ventricular ejection fraction MUGA | Left ventricular ejection fraction Echocardiography
Item
lvef (by muga or echocardiogram) of >=50%.
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Informed Consent | Protocol Compliance
Item
8. the patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Small Molecule EGFR Tyrosine Kinase inhibitors
Item
1. previous treatment with small molecule egfr tyrosine kinase inhibitors
boolean
C1328819 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
Major surgery
Item
2. any major operation within 4 weeks of baseline disease assessment
boolean
C0679637 (UMLS CUI [1])
Abnormality of the gastrointestinal tract Impairing Intake Investigational New Drug | Abnormality of the gastrointestinal tract Impairing Absorption Investigational New Drug
Item
3. any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
boolean
C4023588 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C4023588 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
CNS metastases | Adrenal Cortex Hormones
Item
4. cns metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
boolean
C0686377 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
Lung Disease, Interstitial
Item
5. patients with known interstitial lung disease
boolean
C0206062 (UMLS CUI [1])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant | Acute myocardial infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction low | Congenital long QT syndrome | Ventricular arrhythmia | Second degree atrioventricular block Uncontrolled | Complete atrioventricular block Uncontrolled | Uncontrolled hypertension
Item
6. patients with uncontrolled or significant cardiovascular disease (ami within 12 months,unstable angina within 6 months, nyha class iii, iv congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, congenital long qt syndrome, any significant ventricular arrhythmia, any uncontrolled second or third degree heart block, uncontrolled hypertension)
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0155626 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0428772 (UMLS CUI [6,1])
C0205251 (UMLS CUI [6,2])
C1141890 (UMLS CUI [7])
C0085612 (UMLS CUI [8])
C0264906 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
C0151517 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
C1868885 (UMLS CUI [11])
Malignant Neoplasm Previous | Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Curative treatment Solid Neoplasm | Exception Recurrence Free Duration
Item
7. previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C0280100 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0034897 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
C0449238 (UMLS CUI [7,4])
Pregnancy | Breast Feeding
Item
8. pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Other medical condition Severe Study Subject Participation Status At risk | Other medical condition chronic Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Other medical condition Severe Investigational New Drugs At risk | Other medical condition chronic Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Other medical condition Severe Interferes with Research results | Other medical condition chronic Interferes with Research results | Laboratory test result abnormal Interferes with Research results | Other medical condition Severe Study Subject Participation Status Inappropriate | Other medical condition chronic Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
9. other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C0438215 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C1444641 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0013230 (UMLS CUI [5,3])
C1444641 (UMLS CUI [5,4])
C0438215 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0205191 (UMLS CUI [8,2])
C0521102 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
C0438215 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0683954 (UMLS CUI [9,3])
C3843040 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C2348568 (UMLS CUI [10,3])
C1548788 (UMLS CUI [10,4])
C3843040 (UMLS CUI [11,1])
C0205191 (UMLS CUI [11,2])
C2348568 (UMLS CUI [11,3])
C1548788 (UMLS CUI [11,4])
C0438215 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C1548788 (UMLS CUI [12,3])
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