ID

41154

Beskrivning

A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus; ODM derived from: https://clinicaltrials.gov/show/NCT02017600

Länk

https://clinicaltrials.gov/show/NCT02017600

Nyckelord

Versioner (1)
  1. 02.07.20 02.07.20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2. Juli 2020

DOI

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Creative Commons BY 4.0
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Eligibility Localized Squamous Cell Carcinoma of the Esophagus NCT02017600

Engelsk

Eligibility Localized Squamous Cell Carcinoma of the Esophagus NCT02017600

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).
Beskrivning

Squamous cell carcinoma of esophagus

Datatyp

boolean

Alias
UMLS CUI [1]
C0279626
the tumor had to be locally advanced (stage t2-3/n0, t1-3/n+, if technically resectable with curative intent).
Beskrivning

Locally Advanced Malignant Neoplasm TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677984
UMLS CUI [1,2]
C3258246
patients must be 20 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients must have an ecog performance status score 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
patients must have a life expectancy of at least 12 weeks.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
patients must be accessible for treatment and follow-up at least for one year.
Beskrivning

Patient Available Therapeutic procedure | Patients Available Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C3274571
patients must sign the informed consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patient must have:hemoglobin level 9 g/dl; neutrophil count 1,500/mm3; platelets count 100,000/mm3; serum bilirubin level 1.0 uln; serum transaminase (got, gpt) levels 2.0 uln; serum alkaline phosphatase levels 2.0 uln; serum creatinine level 1.5 mg/dl or creatinine clearance rate(crcl)60 ml/min for the institution (calculated by the cockcroft- gault equation).
Beskrivning

Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201850
UMLS CUI [8]
C0201976
UMLS CUI [9]
C2711451
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.
Beskrivning

Therapeutic radiology procedure Esophageal carcinoma | Chemotherapy Esophageal carcinoma | Cancer treatment Esophageal carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0152018
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0152018
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C0152018
patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.
Beskrivning

Severe allergy Pharmaceutical Preparations | Severe allergy Polysorbate 80

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0032601
major surgery within two weeks prior to entering the study, excluding port-a insertion or feeding jejunostomy surgery.
Beskrivning

Major surgery | Exception Port-A-Cath | Exception Jejunostomy feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3495140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0192715
patients with cns metastasis, including clinical suspicion.
Beskrivning

CNS metastases | Suspicion CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C0686377
patients with clinically detectable peripheral neuropathy 2 on the ctc criteria.
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
mental statuses of patients are not fit for clinical trial.
Beskrivning

Mental state unfit Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0278060
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C0008976
fertile men and women unless using a reliable and appropriate contraceptive method.
Beskrivning

Females & males of reproductive potential | Exception Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C4034483
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0700589
patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception.
Beskrivning

Pregnancy | Breast Feeding | Gender considering Pregnancy | Possible pregnancy | Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0750591
UMLS CUI [3,3]
C0032961
UMLS CUI [4]
C0425965
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C0332197
patients who have serious concomitant illness that might be aggravated by chemotherapy, as below included:active cardiac disease (e.g. congestive heart failure, angina, arrhythmia, acute myocardial disease or other types of heart disease requiring treatment) within 6 months period preceding entry into the study; uncontrolled infection (e.g. active infection that uncontrolled for 2 weeks under antibiotic therapy); retention of body fluid (e.g. pleural effusion, ascites, pericardial effusion, and edema needing treatment); history of other than esophageal cancer, except curatively treated non-melanoma skin cancer or in situ carcinoma of the esophagus; and other conditions which will be judged by physician's discretion.
Beskrivning

Comorbidity Serious | Heart Disease | Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia | Cardiomyopathy | Communicable Disease Uncontrolled | Body fluid retention | Pleural effusion | Ascites | Pericardial effusion | Edema Treatment required for | Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of esophagus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0878544
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C0205318
UMLS CUI [8]
C0268000
UMLS CUI [9]
C0032227
UMLS CUI [10]
C0003962
UMLS CUI [11]
C0031039
UMLS CUI [12,1]
C0013604
UMLS CUI [12,2]
C0332121
UMLS CUI [13]
C1707251
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C1273390
UMLS CUI [14,3]
C0699893
UMLS CUI [15,1]
C1705847
UMLS CUI [15,2]
C1273390
UMLS CUI [15,3]
C0154059
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Similar models

Eligibility Localized Squamous Cell Carcinoma of the Esophagus NCT02017600

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus
Item
patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).
boolean
C0279626 (UMLS CUI [1])
Locally Advanced Malignant Neoplasm TNM clinical staging
Item
the tumor had to be locally advanced (stage t2-3/n0, t1-3/n+, if technically resectable with curative intent).
boolean
C0677984 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Age
Item
patients must be 20 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
patients must have an ecog performance status score 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
patients must have a life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Patient Available Therapeutic procedure | Patients Available Follow-up
Item
patients must be accessible for treatment and follow-up at least for one year.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Informed Consent
Item
patients must sign the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patient must have:hemoglobin level 9 g/dl; neutrophil count 1,500/mm3; platelets count 100,000/mm3; serum bilirubin level 1.0 uln; serum transaminase (got, gpt) levels 2.0 uln; serum alkaline phosphatase levels 2.0 uln; serum creatinine level 1.5 mg/dl or creatinine clearance rate(crcl)60 ml/min for the institution (calculated by the cockcroft- gault equation).
boolean
C0518015 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C2711451 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Esophageal carcinoma | Chemotherapy Esophageal carcinoma | Cancer treatment Esophageal carcinoma
Item
patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.
boolean
C1522449 (UMLS CUI [1,1])
C0152018 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0152018 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3,1])
C0152018 (UMLS CUI [3,2])
Severe allergy Pharmaceutical Preparations | Severe allergy Polysorbate 80
Item
patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.
boolean
C2945656 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
Major surgery | Exception Port-A-Cath | Exception Jejunostomy feeding
Item
major surgery within two weeks prior to entering the study, excluding port-a insertion or feeding jejunostomy surgery.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3495140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0192715 (UMLS CUI [3,2])
CNS metastases | Suspicion CNS metastases
Item
patients with cns metastasis, including clinical suspicion.
boolean
C0686377 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
Peripheral Neuropathy CTCAE Grades
Item
patients with clinically detectable peripheral neuropathy 2 on the ctc criteria.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Mental state unfit Clinical Trial
Item
mental statuses of patients are not fit for clinical trial.
boolean
C0278060 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Females & males of reproductive potential | Exception Contraceptive methods
Item
fertile men and women unless using a reliable and appropriate contraceptive method.
boolean
C4034483 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Gender considering Pregnancy | Possible pregnancy | Contraceptive methods Absent
Item
patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0750591 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0425965 (UMLS CUI [4])
C0700589 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Comorbidity Serious | Heart Disease | Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia | Cardiomyopathy | Communicable Disease Uncontrolled | Body fluid retention | Pleural effusion | Ascites | Pericardial effusion | Edema Treatment required for | Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of esophagus
Item
patients who have serious concomitant illness that might be aggravated by chemotherapy, as below included:active cardiac disease (e.g. congestive heart failure, angina, arrhythmia, acute myocardial disease or other types of heart disease requiring treatment) within 6 months period preceding entry into the study; uncontrolled infection (e.g. active infection that uncontrolled for 2 weeks under antibiotic therapy); retention of body fluid (e.g. pleural effusion, ascites, pericardial effusion, and edema needing treatment); history of other than esophageal cancer, except curatively treated non-melanoma skin cancer or in situ carcinoma of the esophagus; and other conditions which will be judged by physician's discretion.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0878544 (UMLS CUI [6])
C0009450 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0268000 (UMLS CUI [8])
C0032227 (UMLS CUI [9])
C0003962 (UMLS CUI [10])
C0031039 (UMLS CUI [11])
C0013604 (UMLS CUI [12,1])
C0332121 (UMLS CUI [12,2])
C1707251 (UMLS CUI [13])
C1705847 (UMLS CUI [14,1])
C1273390 (UMLS CUI [14,2])
C0699893 (UMLS CUI [14,3])
C1705847 (UMLS CUI [15,1])
C1273390 (UMLS CUI [15,2])
C0154059 (UMLS CUI [15,3])
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