ID

43057

Beskrivning

Radiotherapy Combined With GDP Chemotherapy in Stage I/II Extranodal Natural Killer/T-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02276248

Länk

https://clinicaltrials.gov/show/NCT02276248

Nyckelord

Versioner (1)
  1. 2021-09-17 2021-09-17 -
Rättsinnehavare

Chinese Academy of Medical Sciences

Uppladdad den

17 september 2021

DOI

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Creative Commons BY-NC 4.0
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Eligibility Stage I/II Extranodal NK/T-cell Lymphoma NCT02276248

Engelsk

Eligibility Stage I/II Extranodal NK/T-cell Lymphoma NCT02276248

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of enktl with typical morphology and immunophenotype according to the 2008 world health organization classification of lymphomas;
Beskrivning

Extranodal NK-T-Cell Lymphoma, 2008 world health organization classification of lymphomas

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1955906
UMLS CUI [1,2]
C1301142
2. newly-diagnosed patients;
Beskrivning

Newly diagnosed

Datatyp

boolean

Alias
UMLS CUI [1]
C1518321
3. tumors primarily occurring in the upper aerodigestive tract (nasal cavity, nasopharynx, oral cavity, oropharynx and hypopharynx);
Beskrivning

Primary tumor site in the upper aerodigestive tract

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1267213
UMLS CUI [1,2]
C0475447
4. ann arbor stage i/ii;
Beskrivning

Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1]
C0432516
5. age ≥ 18 years;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
6. eastern cooperative oncology group (ecog) performance status 0-2;
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
7. at least one measurable lesion;
Beskrivning

Quantity of measurable leisons

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
8. adequate hematologic, hepatic, and renal functions: absolute neutrophil count ≥1.5×109/l, platelet count ≥ 100×109/l, total bilirubin ≤ 1.5 × upper limit of normal, ast and alt ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
Beskrivning

Absolute neutrophil count | Platelet count measurement | Total bilirubin measurement | AST | ALT | Creatinine measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201976
9. with at least one unfavorable prognostic factor (age ＞ 60 years; b symptoms; elevated lactate dehydrogenase; regional node involvement; local tumor invasion: bone or skin; histologic elevation of high ki-67 staining)
Beskrivning

Unfavorable prognostic factor | Age | b symptoms | Elevated lactate dehydrogenase | Regional node involvement | Local tumor invasion | Ki-67 Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514474
UMLS CUI [1,2]
C3640815
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1706867
UMLS CUI [4]
C0202113
UMLS CUI [5,1]
C0806692
UMLS CUI [5,2]
C0205147
UMLS CUI [6]
C1300092
UMLS CUI [7]
C4049944
10. life expectancy of more 3 months;
Beskrivning

Life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
11. informed consent.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who received prior treatment;
Beskrivning

Prior therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
2. stage i/ii patients without unfavorable prognostic factors;
Beskrivning

Ann Arbor lymphoma staging system, absence of unfavorable prognostic factors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0432516
UMLS CUI [1,2]
C1514474
UMLS CUI [1,3]
C3640815
UMLS CUI [1,4]
C0332197
3. tumors primarily occurring in the extra-upper aerodigestive tract (e.g., skin, testis, intestine, muscle and so on);
Beskrivning

Primary site of tumor in extra-upper aerodigestive tract

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475447
UMLS CUI [1,2]
C1267213
UMLS CUI [1,3]
C1705847
4. pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception;
Beskrivning

Pregnancy | Breast Feeding | Childbearing potential without adequate contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
5. patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
Beskrivning

Other primary cancer except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0007114
UMLS CUI [1,3]
C1518408
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0205411
UMLS CUI [1,6]
C1705847
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1273390
UMLS CUI [2,4]
C1705847
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0012634
UMLS CUI [3,4]
C0332120
UMLS CUI [3,5]
C0332197
UMLS CUI [3,6]
C1705847
6. patients with defect of central nervous system (cns) or any psychiatric disorders and cns metastases
Beskrivning

CNS disorder | Mental disorder | CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0686377
7. other serious illness or medical conditions a. clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [nyha class iii or iv], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 av block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry b. liver cirrhosis (≥ child-pugh class b) c. history of significant neurologic or psychiatric disorders including dementia or seizures d. active uncontrolled infection e. other serious underlying medical conditions which could impair the ability of the patient to participate in the study
Beskrivning

Clinically significant cardiac disease | Liver cirrhosis | History of psychiatric or neurologic disease | Active uncontrolled infection | Other serious disease or condition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0023890
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0004936
UMLS CUI [3,3]
C0027765
UMLS CUI [3,4]
C2826293
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0205177
UMLS CUI [5,1]
C2359476
UMLS CUI [5,2]
C0205404
8. systemic anticancer therapy within 30 days before inclusion in this study.
Beskrivning

Recent systemic anticancer therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332185
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Similar models

Eligibility Stage I/II Extranodal NK/T-cell Lymphoma NCT02276248

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Extranodal NK-T-Cell Lymphoma, 2008 world health organization classification of lymphomas
Item
1. diagnosis of enktl with typical morphology and immunophenotype according to the 2008 world health organization classification of lymphomas;
boolean
C1955906 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Newly diagnosed
Item
2. newly-diagnosed patients;
boolean
C1518321 (UMLS CUI [1])
Primary tumor site in the upper aerodigestive tract
Item
3. tumors primarily occurring in the upper aerodigestive tract (nasal cavity, nasopharynx, oral cavity, oropharynx and hypopharynx);
boolean
C1267213 (UMLS CUI [1,1])
C0475447 (UMLS CUI [1,2])
Ann Arbor lymphoma staging system
Item
4. ann arbor stage i/ii;
boolean
C0432516 (UMLS CUI [1])
Age
Item
5. age ≥ 18 years;
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance status 0-2;
boolean
C1520224 (UMLS CUI [1])
Quantity of measurable leisons
Item
7. at least one measurable lesion;
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Absolute neutrophil count | Platelet count measurement | Total bilirubin measurement | AST | ALT | Creatinine measurement
Item
8. adequate hematologic, hepatic, and renal functions: absolute neutrophil count ≥1.5×109/l, platelet count ≥ 100×109/l, total bilirubin ≤ 1.5 × upper limit of normal, ast and alt ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Unfavorable prognostic factor | Age | b symptoms | Elevated lactate dehydrogenase | Regional node involvement | Local tumor invasion | Ki-67 Measurement
Item
9. with at least one unfavorable prognostic factor (age ＞ 60 years; b symptoms; elevated lactate dehydrogenase; regional node involvement; local tumor invasion: bone or skin; histologic elevation of high ki-67 staining)
boolean
C1514474 (UMLS CUI [1,1])
C3640815 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C1706867 (UMLS CUI [3])
C0202113 (UMLS CUI [4])
C0806692 (UMLS CUI [5,1])
C0205147 (UMLS CUI [5,2])
C1300092 (UMLS CUI [6])
C4049944 (UMLS CUI [7])
Life expectancy
Item
10. life expectancy of more 3 months;
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
11. informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior therapy
Item
1. patients who received prior treatment;
boolean
C1514463 (UMLS CUI [1])
Ann Arbor lymphoma staging system, absence of unfavorable prognostic factors
Item
2. stage i/ii patients without unfavorable prognostic factors;
boolean
C0432516 (UMLS CUI [1,1])
C1514474 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Primary site of tumor in extra-upper aerodigestive tract
Item
3. tumors primarily occurring in the extra-upper aerodigestive tract (e.g., skin, testis, intestine, muscle and so on);
boolean
C0475447 (UMLS CUI [1,1])
C1267213 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing potential without adequate contraception
Item
4. pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Other primary cancer except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease
Item
5. patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
boolean
C0006826 (UMLS CUI [1,1])
C0007114 (UMLS CUI [1,2])
C1518408 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0205411 (UMLS CUI [1,5])
C1705847 (UMLS CUI [1,6])
C0006826 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1273390 (UMLS CUI [2,3])
C1705847 (UMLS CUI [2,4])
C0006826 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C0332120 (UMLS CUI [3,4])
C0332197 (UMLS CUI [3,5])
C1705847 (UMLS CUI [3,6])
CNS disorder | Mental disorder | CNS metastases
Item
6. patients with defect of central nervous system (cns) or any psychiatric disorders and cns metastases
boolean
C0007682 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0686377 (UMLS CUI [3])
Clinically significant cardiac disease | Liver cirrhosis | History of psychiatric or neurologic disease | Active uncontrolled infection | Other serious disease or condition
Item
7. other serious illness or medical conditions a. clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [nyha class iii or iv], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 av block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry b. liver cirrhosis (≥ child-pugh class b) c. history of significant neurologic or psychiatric disorders including dementia or seizures d. active uncontrolled infection e. other serious underlying medical conditions which could impair the ability of the patient to participate in the study
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
C0262926 (UMLS CUI [3,1])
C0004936 (UMLS CUI [3,2])
C0027765 (UMLS CUI [3,3])
C2826293 (UMLS CUI [3,4])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0205177 (UMLS CUI [4,3])
C2359476 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
Recent systemic anticancer therapy
Item
8. systemic anticancer therapy within 30 days before inclusion in this study.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
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