ID

36553

Beskrivning

Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02016417

Länk

https://clinicaltrials.gov/show/NCT02016417

Nyckelord

Versioner (2)
  1. 2019-05-21 2019-05-21 -
  2. 2019-05-21 2019-05-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT02016417

Engelsk

Eligibility Nasopharyngeal Carcinoma NCT02016417

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with newly histologically confirmed non-keratinizing (according to who histologically type).
Beskrivning

Nasopharyngeal Nonkeratinizing Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1334926
2. 18 years to 70 years;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. tumor staged as t3-4n1/n2-3m0 (according to the 7th ajcc edition),
Beskrivning

Neoplasm TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3258246
4. performance status: karnofsky scale (kps) > 70 (appendix i ).
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
5. adequate marrow: leucocyte count > 4×109/l, neutrophil count > 2×109/l, hemoglobin > 90g/l and platelet count > 100×109/l.
Beskrivning

Bone Marrow function | White Blood Cell Count procedure | Neutrophil count (procedure) | Hemoglobin measurement | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0032181
6. normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) < 2.5×uln, and bilirubin < uln.
Beskrivning

Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201850
UMLS CUI [5]
C1278039
7. adequate renal function: creatinine clearance > 60 ml/min.
Beskrivning

Renal function | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0373595
8. patients must be informed of the investigational nature of this study and give written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Beskrivning

Squamous cell carcinoma, keratinizing | Basaloid squamous cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0334247
UMLS CUI [2]
C1266005
2. age > 70 or < 18.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. treatment with palliative intent.
Beskrivning

Therapeutic procedure Palliative intent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1285530
4. prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
5. pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Tests | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
6. history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
Beskrivning

Prior radiation therapy | Exception Therapeutic radiology procedure Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0699893
7. prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Beskrivning

Prior Chemotherapy Primary tumor | Operative Surgical Procedures Primary tumor | Prior Chemotherapy Lymph nodes | Operative Surgical Procedures Lymph nodes | Exception Diagnostic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0677930
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0024204
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0024204
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0430022
8. any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×uln), and emotional disturbance.
Beskrivning

Comorbidity Severe At risk Clinical Trial | Comorbidity Severe Affecting Clinical Trial | Heart Disease Unstable Treatment required for | Kidney Disease | Hepatitis, Chronic | Diabetes mellitus poor control | Elevated fasting plasma glucose | Emotional Disturbance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0008976
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0008976
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [3,3]
C0332121
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0019189
UMLS CUI [6]
C0860161
UMLS CUI [7]
C4228506
UMLS CUI [8]
C0013985
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT02016417

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal Nonkeratinizing Carcinoma
Item
1. patients with newly histologically confirmed non-keratinizing (according to who histologically type).
boolean
C1334926 (UMLS CUI [1])
Age
Item
2. 18 years to 70 years;
boolean
C0001779 (UMLS CUI [1])
Neoplasm TNM clinical staging
Item
3. tumor staged as t3-4n1/n2-3m0 (according to the 7th ajcc edition),
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
4. performance status: karnofsky scale (kps) > 70 (appendix i ).
boolean
C0206065 (UMLS CUI [1])
Bone Marrow function | White Blood Cell Count procedure | Neutrophil count (procedure) | Hemoglobin measurement | Platelet Count measurement
Item
5. adequate marrow: leucocyte count > 4×109/l, neutrophil count > 2×109/l, hemoglobin > 90g/l and platelet count > 100×109/l.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement
Item
6. normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) < 2.5×uln, and bilirubin < uln.
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Renal function | Creatinine clearance measurement
Item
7. adequate renal function: creatinine clearance > 60 ml/min.
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Informed Consent
Item
8. patients must be informed of the investigational nature of this study and give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Squamous cell carcinoma, keratinizing | Basaloid squamous cell carcinoma
Item
1. who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
boolean
C0334247 (UMLS CUI [1])
C1266005 (UMLS CUI [2])
Age
Item
2. age > 70 or < 18.
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Palliative intent
Item
3. treatment with palliative intent.
boolean
C0087111 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix
Item
4. prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Tests | Childbearing Potential Contraceptive methods
Item
5. pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Prior radiation therapy | Exception Therapeutic radiology procedure Skin carcinoma
Item
6. history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
boolean
C0279134 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
Prior Chemotherapy Primary tumor | Operative Surgical Procedures Primary tumor | Prior Chemotherapy Lymph nodes | Operative Surgical Procedures Lymph nodes | Exception Diagnostic procedure
Item
7. prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
boolean
C1514457 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0024204 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0430022 (UMLS CUI [5,2])
Comorbidity Severe At risk Clinical Trial | Comorbidity Severe Affecting Clinical Trial | Heart Disease Unstable Treatment required for | Kidney Disease | Hepatitis, Chronic | Diabetes mellitus poor control | Elevated fasting plasma glucose | Emotional Disturbance
Item
8. any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×uln), and emotional disturbance.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0332121 (UMLS CUI [3,3])
C0022658 (UMLS CUI [4])
C0019189 (UMLS CUI [5])
C0860161 (UMLS CUI [6])
C4228506 (UMLS CUI [7])
C0013985 (UMLS CUI [8])
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