ID

15629

Beschrijving

Concurrent Chemotherapy in Intermediate Risk Patients Treated With Intensity-modulated Radiotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02289807

Link

https://clinicaltrials.gov/show/NCT02289807

Trefwoorden

Versies (1)
  1. 06-06-16 06-06-16 -
Geüploaded op

6 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT02289807

Engels

Eligibility Nasopharyngeal Carcinoma NCT02289807

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Nasopharyngeal Nonkeratinizing Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C1334926
tumor staged as t1-2n1/t2-3n0(according to the 7th ajcc edition). no evidence of distant metastasis (m0). satisfactory performance status: karnofsky scale (kps) ≥ 70. adequate marrow: leucocyte count ≥ 4000/μl, hemoglobin ≥ 90g/l and platelet count ≥ 100000/μl.
Beschrijving

TNM Staging System | M - Distant metastasis stage | Karnofsky Performance Status | Bone Marrow | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1515169
UMLS CUI [2]
C0449916
UMLS CUI [3]
C0206065
UMLS CUI [4]
C0005953
UMLS CUI [5]
C0023508
UMLS CUI [6]
C0518015
UMLS CUI [7]
C0032181
normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤
Beschrijving

Liver function tests normal | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0438235
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201850
2.5×uln, and bilirubin ≤ uln.
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
adequate renal function: creatinine clearance ≥ 60 ml/min. patients must be informed of the investigational nature of this study and give written informed consent.
Beschrijving

Renal function | Creatinine clearance measurement | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

WHO tumor classification | Squamous cell carcinoma, keratinizing | Basaloid squamous cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C1301142
UMLS CUI [2]
C0334247
UMLS CUI [3]
C1266005
age > 65 or < 18. treatment with palliative intent. prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Beschrijving

Age | Palliative Care | Malignant Neoplasms Previous | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0030231
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0205156
UMLS CUI [4]
C0007117
UMLS CUI [5]
C0553723
UMLS CUI [6]
C0851140
pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032976
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0001779
UMLS CUI [5]
C0700589
history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
Beschrijving

prior radiation therapy | Malignant neoplasm of skin | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C0007114
UMLS CUI [3]
C1522449
prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 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.
Beschrijving

Prior Chemotherapy | Operative Surgical Procedures Previous | Operative Surgical Procedures Diagnostic | primary tumor | lymph nodes | Intercurrent disease Risk | Compliance behavior Limited | Heart Diseases Unstable status | Kidney Diseases | Hepatitis, Chronic | Diabetes mellitus poor control | Plasma fasting glucose measurement | Emotional Disturbances

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0348026
UMLS CUI [4]
C0677930
UMLS CUI [5]
C0024204
UMLS CUI [6,1]
C0277557
UMLS CUI [6,2]
C0035647
UMLS CUI [7,1]
C1321605
UMLS CUI [7,2]
C0439801
UMLS CUI [8,1]
C0018799
UMLS CUI [8,2]
C0443343
UMLS CUI [9]
C0022658
UMLS CUI [10]
C0019189
UMLS CUI [11]
C0860161
UMLS CUI [12]
C0583513
UMLS CUI [13]
C0013985
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT02289807

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal Nonkeratinizing Carcinoma
Item
patients with newly histologically confirmed non-keratinizing (according to who histologically type).
boolean
C1334926 (UMLS CUI [1])
TNM Staging System | M - Distant metastasis stage | Karnofsky Performance Status | Bone Marrow | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement
Item
tumor staged as t1-2n1/t2-3n0(according to the 7th ajcc edition). no evidence of distant metastasis (m0). satisfactory performance status: karnofsky scale (kps) ≥ 70. adequate marrow: leucocyte count ≥ 4000/μl, hemoglobin ≥ 90g/l and platelet count ≥ 100000/μl.
boolean
C1515169 (UMLS CUI [1])
C0449916 (UMLS CUI [2])
C0206065 (UMLS CUI [3])
C0005953 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
Liver function tests normal | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement
Item
normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤
boolean
C0438235 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Serum total bilirubin measurement
Item
2.5×uln, and bilirubin ≤ uln.
boolean
C1278039 (UMLS CUI [1])
Renal function | Creatinine clearance measurement | Informed Consent
Item
adequate renal function: creatinine clearance ≥ 60 ml/min. patients must be informed of the investigational nature of this study and give written informed consent.
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
WHO tumor classification | Squamous cell carcinoma, keratinizing | Basaloid squamous cell carcinoma
Item
who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
boolean
C1301142 (UMLS CUI [1])
C0334247 (UMLS CUI [2])
C1266005 (UMLS CUI [3])
Age | Palliative Care | Malignant Neoplasms Previous | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix
Item
age > 65 or < 18. treatment with palliative intent. prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
boolean
C0001779 (UMLS CUI [1])
C0030231 (UMLS CUI [2])
C0006826 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0007117 (UMLS CUI [4])
C0553723 (UMLS CUI [5])
C0851140 (UMLS CUI [6])
Pregnancy | Breast Feeding | Pregnancy Tests | Childbearing Potential Age | Contraceptive methods
Item
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])
C0032976 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0001779 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5])
prior radiation therapy | Malignant neoplasm of skin | Therapeutic radiology procedure
Item
history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
boolean
C0279134 (UMLS CUI [1])
C0007114 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Prior Chemotherapy | Operative Surgical Procedures Previous | Operative Surgical Procedures Diagnostic | primary tumor | lymph nodes | Intercurrent disease Risk | Compliance behavior Limited | Heart Diseases Unstable status | Kidney Diseases | Hepatitis, Chronic | Diabetes mellitus poor control | Plasma fasting glucose measurement | Emotional Disturbances
Item
prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 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
C1514457 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0348026 (UMLS CUI [3,2])
C0677930 (UMLS CUI [4])
C0024204 (UMLS CUI [5])
C0277557 (UMLS CUI [6,1])
C0035647 (UMLS CUI [6,2])
C1321605 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0018799 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0022658 (UMLS CUI [9])
C0019189 (UMLS CUI [10])
C0860161 (UMLS CUI [11])
C0583513 (UMLS CUI [12])
C0013985 (UMLS CUI [13])
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