ID

39275

Beschrijving

Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy; ODM derived from: https://clinicaltrials.gov/show/NCT01402180

Link

https://clinicaltrials.gov/show/NCT01402180

Trefwoorden

  1. 16-12-19 16-12-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 december 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Esophageal Squamous Cell Carcinoma NCT01402180

Eligibility Esophageal Squamous Cell Carcinoma NCT01402180

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥ 18 and ≤75
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. ecog performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
3. histologically proven primary thoracic esophageal squamous cell carcinoma before
Beschrijving

Oesophageal squamous cell carcinoma thoracic

Datatype

boolean

Alias
UMLS CUI [1]
C0861674
4. diagnosis of regional lymph nodes (biosupravascular fossa or upper mediastinum) recurrence after radical esophagectomy, based on pathological finding or imaging showing lymph nodes enlargement
Beschrijving

Regional lymph nodes Recurrence | Other Coding | Mediastinum Upper | Status post Esophagectomy Radical | Pathology | Lymphadenopathy Imaging

Datatype

boolean

Alias
UMLS CUI [1,1]
C1179441
UMLS CUI [1,2]
C0034897
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C0025066
UMLS CUI [3,2]
C1282910
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0085198
UMLS CUI [4,3]
C0439807
UMLS CUI [5]
C09195386
UMLS CUI [6,1]
C0497156
UMLS CUI [6,2]
C0011923
5. period from esophagectomy to diagnosis of regional lymph nodes recurrence should be more than 6 months
Beschrijving

Period | Esophagectomy | Regional lymph nodes Recurrence

Datatype

boolean

Alias
UMLS CUI [1]
C1948053
UMLS CUI [2]
C0085198
UMLS CUI [3,1]
C1179441
UMLS CUI [3,2]
C0034897
6. without prior radiotherapy
Beschrijving

Prior radiation therapy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0332197
7. weight loss no more than 10% in the past 6 months
Beschrijving

Weight loss Percentage Timespan

Datatype

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
8. wbc≥ 4.0x109/l ,absolute neutrophil count (anc) ≥ 2.0x109/l
Beschrijving

White Blood Cell Count procedure | Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
9. platelets ≥ 100x109/l
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
10. hemoglobin ≥ 90g/l(without blood transfusion)
Beschrijving

Hemoglobin measurement | Blood Transfusion Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C0005841
UMLS CUI [2,2]
C0332197
11. ast (sgot)/alt (sgpt) ≤ 2.5 x upper limit of normal, bilirubin ≤ 1.5 x upper limit of normal
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
12. creatinine ≤ 1.5 x upper limit of normal
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
13. sign study-specific informed consent prior to study entry
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. with recurrence or metastasis other than regional lymph nodes (biosupravascular fossa or upper mediastinum)
Beschrijving

Disease recurrence | Neoplasm Metastasis | Exception Regional lymph nodes

Datatype

boolean

Alias
UMLS CUI [1]
C0679254
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1179441
2. prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
Beschrijving

invasive cancer Previous | Exception Skin carcinoma | Exception Disease Free Duration | Exception Carcinoma in situ of female breast | Exception Carcinoma in situ of mouth | Exception Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0686288
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0347073
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
3. severe, active comorbidity, defined as follows:
Beschrijving

Comorbidity Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
3.1 unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 transmural myocardial infarction within the last 6 months 3.3 acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 acquired immune deficiency syndrome (aids) based upon current cdc definition; note, however, that hiv testing is not required for entry into this protocol. the need to exclude patients with aids from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Beschrijving

Angina, Unstable | Congestive heart failure Hospitalization Required | Transmural myocardial infarction | Bacterial Infections | Mycoses | Requirement Antibiotics Intravenous | COPD exacerbation | Respiration Disorders Hospitalization Required | Respiration Disorders Exclude Investigational Therapies | AIDS

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1708385
UMLS CUI [3]
C1400513
UMLS CUI [4]
C0004623
UMLS CUI [5]
C0026946
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0003232
UMLS CUI [6,3]
C1522726
UMLS CUI [7]
C0740304
UMLS CUI [8,1]
C0035204
UMLS CUI [8,2]
C1708385
UMLS CUI [9,1]
C0035204
UMLS CUI [9,2]
C0332196
UMLS CUI [9,3]
C0949266
UMLS CUI [10]
C0001175
4. pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
Beschrijving

Pregnancy | Childbearing Potential Sexually active Contraceptive methods Unwilling | Childbearing Potential Sexually active Contraceptive methods Unable | Gender Sexually active Contraceptive methods Unwilling | Gender Sexually active Contraceptive methods Unable

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C0558080
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C1299582
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
UMLS CUI [4,4]
C0558080
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0241028
UMLS CUI [5,3]
C0700589
UMLS CUI [5,4]
C1299582
5. prior radiation therapy or prior target drug therapy
Beschrijving

Prior radiation therapy | Pharmacotherapy Targeted

Datatype

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C1521840

Similar models

Eligibility Esophageal Squamous Cell Carcinoma NCT01402180

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥ 18 and ≤75
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Oesophageal squamous cell carcinoma thoracic
Item
3. histologically proven primary thoracic esophageal squamous cell carcinoma before
boolean
C0861674 (UMLS CUI [1])
Regional lymph nodes Recurrence | Other Coding | Mediastinum Upper | Status post Esophagectomy Radical | Pathology | Lymphadenopathy Imaging
Item
4. diagnosis of regional lymph nodes (biosupravascular fossa or upper mediastinum) recurrence after radical esophagectomy, based on pathological finding or imaging showing lymph nodes enlargement
boolean
C1179441 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
C0025066 (UMLS CUI [3,1])
C1282910 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0085198 (UMLS CUI [4,2])
C0439807 (UMLS CUI [4,3])
C09195386 (UMLS CUI [5])
C0497156 (UMLS CUI [6,1])
C0011923 (UMLS CUI [6,2])
Period | Esophagectomy | Regional lymph nodes Recurrence
Item
5. period from esophagectomy to diagnosis of regional lymph nodes recurrence should be more than 6 months
boolean
C1948053 (UMLS CUI [1])
C0085198 (UMLS CUI [2])
C1179441 (UMLS CUI [3,1])
C0034897 (UMLS CUI [3,2])
Prior radiation therapy Absent
Item
6. without prior radiotherapy
boolean
C0279134 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Weight loss Percentage Timespan
Item
7. weight loss no more than 10% in the past 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
White Blood Cell Count procedure | Absolute neutrophil count
Item
8. wbc≥ 4.0x109/l ,absolute neutrophil count (anc) ≥ 2.0x109/l
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Platelet Count measurement
Item
9. platelets ≥ 100x109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement | Blood Transfusion Absent
Item
10. hemoglobin ≥ 90g/l(without blood transfusion)
boolean
C0518015 (UMLS CUI [1])
C0005841 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
11. ast (sgot)/alt (sgpt) ≤ 2.5 x upper limit of normal, bilirubin ≤ 1.5 x upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Creatinine measurement, serum
Item
12. creatinine ≤ 1.5 x upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
13. sign study-specific informed consent prior to study entry
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease recurrence | Neoplasm Metastasis | Exception Regional lymph nodes
Item
1. with recurrence or metastasis other than regional lymph nodes (biosupravascular fossa or upper mediastinum)
boolean
C0679254 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1179441 (UMLS CUI [3,2])
invasive cancer Previous | Exception Skin carcinoma | Exception Disease Free Duration | Exception Carcinoma in situ of female breast | Exception Carcinoma in situ of mouth | Exception Carcinoma in situ of uterine cervix
Item
2. prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
boolean
C0677898 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0686288 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0347073 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
Comorbidity Severe
Item
3. severe, active comorbidity, defined as follows:
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Angina, Unstable | Congestive heart failure Hospitalization Required | Transmural myocardial infarction | Bacterial Infections | Mycoses | Requirement Antibiotics Intravenous | COPD exacerbation | Respiration Disorders Hospitalization Required | Respiration Disorders Exclude Investigational Therapies | AIDS
Item
3.1 unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 transmural myocardial infarction within the last 6 months 3.3 acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 acquired immune deficiency syndrome (aids) based upon current cdc definition; note, however, that hiv testing is not required for entry into this protocol. the need to exclude patients with aids from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
boolean
C0002965 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1708385 (UMLS CUI [2,2])
C1400513 (UMLS CUI [3])
C0004623 (UMLS CUI [4])
C0026946 (UMLS CUI [5])
C1514873 (UMLS CUI [6,1])
C0003232 (UMLS CUI [6,2])
C1522726 (UMLS CUI [6,3])
C0740304 (UMLS CUI [7])
C0035204 (UMLS CUI [8,1])
C1708385 (UMLS CUI [8,2])
C0035204 (UMLS CUI [9,1])
C0332196 (UMLS CUI [9,2])
C0949266 (UMLS CUI [9,3])
C0001175 (UMLS CUI [10])
Pregnancy | Childbearing Potential Sexually active Contraceptive methods Unwilling | Childbearing Potential Sexually active Contraceptive methods Unable | Gender Sexually active Contraceptive methods Unwilling | Gender Sexually active Contraceptive methods Unable
Item
4. pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
C0079399 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])
C0079399 (UMLS CUI [5,1])
C0241028 (UMLS CUI [5,2])
C0700589 (UMLS CUI [5,3])
C1299582 (UMLS CUI [5,4])
Prior radiation therapy | Pharmacotherapy Targeted
Item
5. prior radiation therapy or prior target drug therapy
boolean
C0279134 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])

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