ID

36570

Beschreibung

A Phase III Trial in NPC With Post-radiation Detectable Plasma EBV DNA; ODM derived from: https://clinicaltrials.gov/show/NCT02363400

Link

https://clinicaltrials.gov/show/NCT02363400

Stichworte

Versionen (2)
  1. 21/05/2019 21/05/2019 -
  2. 22/05/2019 22/05/2019 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22 de maio de 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT02363400

Englisch

Eligibility Nasopharyngeal Carcinoma NCT02363400

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1.histological proven npc.
Beschreibung

Nasopharyngeal carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2931822
2.2010 ajcc stage ii-ivb.
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
3.age ≧ 20 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4.performance status of ecog ≦ 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5.finished rt ≧ 66 gy (± induction and/or concurrent chemotherapy).
Beschreibung

Therapeutic radiology procedure Completed | Induction Chemotherapy | Induction Chemotherapy Absent | Chemotherapy | Chemotherapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C3179010
UMLS CUI [3,1]
C3179010
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0392920
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0332197
6.pebv dna > 0 copy/ml at 1±1 week post-rt.
Beschreibung

Epstein-Barr virus DNA Measurement | Status post Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0369169
UMLS CUI [1,2]
C0242485
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1522449
7.re-staging work-ups at 10±2 weeks post-rt showing no active lesions.
Beschreibung

Lesion Absent | Status post Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1522449
8.adequate liver, renal, and bone marrow function 4 weeks before randomization.
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
9.signed informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pathologically-proven the presence of locoregional disease and/or distant metastasis.
Beschreibung

Disease Locoregional | Distant metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1947913
UMLS CUI [2]
C1269798
2. unequivocally-shown active npc (locoregional/distant) by imaging studies.
Beschreibung

Nasopharyngeal carcinoma Locoregional Imaging study | Nasopharyngeal carcinoma Distant Imaging study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C1947913
UMLS CUI [1,3]
C1881134
UMLS CUI [2,1]
C2931822
UMLS CUI [2,2]
C0443203
UMLS CUI [2,3]
C1881134
3. inadequate rt.
Beschreibung

Therapeutic radiology procedure Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205412
4. received any post-rt adjuvant chemotherapy.
Beschreibung

Adjuvant Chemotherapy Post Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1522449
5. pebv dna = 0 copy/ml at 1±1 week post-rt.
Beschreibung

Epstein-Barr virus DNA Measurement | Status post Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0369169
UMLS CUI [1,2]
C0242485
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1522449
6. previous delivery of cisplatin dose > 600 mg/m2.
Beschreibung

Cisplatin Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008838
UMLS CUI [1,2]
C0178602
7. previous delivery of epirubicin > 360 mg/m2.
Beschreibung

Epirubicin Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0014582
UMLS CUI [1,2]
C0178602
8. history of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (dcis) of breast.
Beschreibung

Malignant Neoplasms | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment DCIS

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007124
9. severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
Beschreibung

Disease Cardiopulmonary Severe | Angina, Unstable | Congestive heart failure | Peripheral Vascular Disease Hospitalization Required | COPD exacerbation | Respiration Disorders Hospitalization Required | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0553534
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0085096
UMLS CUI [4,2]
C1708385
UMLS CUI [5]
C0740304
UMLS CUI [6,1]
C0035204
UMLS CUI [6,2]
C1708385
UMLS CUI [7]
C0004936
10. female patients who are pregnant or lactating.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Eligibility Nasopharyngeal Carcinoma NCT02363400

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma
Item
1.histological proven npc.
boolean
C2931822 (UMLS CUI [1])
TNM clinical staging
Item
2.2010 ajcc stage ii-ivb.
boolean
C3258246 (UMLS CUI [1])
Age
Item
3.age ≧ 20 years old.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4.performance status of ecog ≦ 2.
boolean
C1520224 (UMLS CUI [1])
Therapeutic radiology procedure Completed | Induction Chemotherapy | Induction Chemotherapy Absent | Chemotherapy | Chemotherapy Absent
Item
5.finished rt ≧ 66 gy (± induction and/or concurrent chemotherapy).
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C3179010 (UMLS CUI [2])
C3179010 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Epstein-Barr virus DNA Measurement | Status post Therapeutic radiology procedure
Item
6.pebv dna > 0 copy/ml at 1±1 week post-rt.
boolean
C0369169 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Lesion Absent | Status post Therapeutic radiology procedure
Item
7.re-staging work-ups at 10±2 weeks post-rt showing no active lesions.
boolean
C0221198 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Liver function | Renal function | Bone Marrow function
Item
8.adequate liver, renal, and bone marrow function 4 weeks before randomization.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Informed Consent
Item
9.signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Locoregional | Distant metastasis
Item
1. pathologically-proven the presence of locoregional disease and/or distant metastasis.
boolean
C0012634 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2])
Nasopharyngeal carcinoma Locoregional Imaging study | Nasopharyngeal carcinoma Distant Imaging study
Item
2. unequivocally-shown active npc (locoregional/distant) by imaging studies.
boolean
C2931822 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C1881134 (UMLS CUI [1,3])
C2931822 (UMLS CUI [2,1])
C0443203 (UMLS CUI [2,2])
C1881134 (UMLS CUI [2,3])
Therapeutic radiology procedure Inadequate
Item
3. inadequate rt.
boolean
C1522449 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Adjuvant Chemotherapy Post Therapeutic radiology procedure
Item
4. received any post-rt adjuvant chemotherapy.
boolean
C0085533 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
Epstein-Barr virus DNA Measurement | Status post Therapeutic radiology procedure
Item
5. pebv dna = 0 copy/ml at 1±1 week post-rt.
boolean
C0369169 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Cisplatin Dose
Item
6. previous delivery of cisplatin dose > 600 mg/m2.
boolean
C0008838 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Epirubicin Dose
Item
7. previous delivery of epirubicin > 360 mg/m2.
boolean
C0014582 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment DCIS
Item
8. history of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (dcis) of breast.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007124 (UMLS CUI [4,3])
Disease Cardiopulmonary Severe | Angina, Unstable | Congestive heart failure | Peripheral Vascular Disease Hospitalization Required | COPD exacerbation | Respiration Disorders Hospitalization Required | Mental disorders
Item
9. severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
boolean
C0012634 (UMLS CUI [1,1])
C0553534 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0085096 (UMLS CUI [4,1])
C1708385 (UMLS CUI [4,2])
C0740304 (UMLS CUI [5])
C0035204 (UMLS CUI [6,1])
C1708385 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
10. female patients who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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