ID

39266

Beschrijving

A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01391572

Link

https://clinicaltrials.gov/show/NCT01391572

Trefwoorden

  1. 14-12-19 14-12-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 december 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

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Eligibility Esophageal Squamous Cell Carcinoma NCT01391572

Eligibility Esophageal Squamous Cell Carcinoma NCT01391572

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥ 18 and ≤70
Beschrijving

Age

Datatype

boolean

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

Performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
3. weight is not less than 90% of it before operation
Beschrijving

Body Weight Postoperative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0032790
4. registration within 8 weeks after esophagectomy
Beschrijving

Enrollment Post Esophagectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0085198
5. histologically proven primary thoracic esophageal squamous cell carcinoma
Beschrijving

Squamous cell carcinoma of esophagus thoracic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279626
UMLS CUI [1,2]
C0817096
6. r0 resection and number of lymph nodes dissected ≥15 after esophagectomy
Beschrijving

Excision TNM clinical staging | Lymph Node Dissection Number Lymph nodes | Status post Esophagectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0242382
UMLS CUI [2,2]
C0237753
UMLS CUI [2,3]
C0024204
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0085198
7. pathological stage of t3-4n0-3m0
Beschrijving

Pathological staging

Datatype

boolean

Alias
UMLS CUI [1]
C0443276
8. chest and abdominal contrast enhanced ct within 6 weeks prior to registration(pet/ct scan is selective)
Beschrijving

CT of thorax and abdomen with contrast | PET/CT scan

Datatype

boolean

Alias
UMLS CUI [1]
C2317249
UMLS CUI [2]
C1699633
9. without supraclavicular nodes and abdominal regions nodes existed after surgery
Beschrijving

Supraclavicular lymph nodes Absent | Abdominal lymph nodes Absent | Status post Operative Surgical Procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0229730
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0588058
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
10. without neo-adjuvant chemotherapy and radiotherapy
Beschrijving

Neoadjuvant Chemotherapy Absent | Therapeutic radiology procedure Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
11. 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
12. platelets ≥ 100x109/l
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
13. 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
14. 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
15. creatinine ≤ 1.5 x upper limit of normal
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
16. 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. multiple primary esophageal tumors
Beschrijving

Esophageal Neoplasms Primary multiple

Datatype

boolean

Alias
UMLS CUI [1,1]
C0014859
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0439064
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 | 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]
C0677898
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 systemic chemotherapy, prior radiation therapy or prior target drug therapy
Beschrijving

Systemic Chemotherapy | Prior radiation therapy | Pharmacotherapy Targeted

Datatype

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2]
C0279134
UMLS CUI [3,1]
C0013216
UMLS CUI [3,2]
C1521840

Similar models

Eligibility Esophageal Squamous Cell Carcinoma NCT01391572

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥ 18 and ≤70
boolean
C0001779 (UMLS CUI [1])
Performance status
Item
2. performance status 0-1
boolean
C1518965 (UMLS CUI [1])
Body Weight Postoperative
Item
3. weight is not less than 90% of it before operation
boolean
C0005910 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
Enrollment Post Esophagectomy
Item
4. registration within 8 weeks after esophagectomy
boolean
C1516879 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0085198 (UMLS CUI [1,3])
Squamous cell carcinoma of esophagus thoracic
Item
5. histologically proven primary thoracic esophageal squamous cell carcinoma
boolean
C0279626 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
Excision TNM clinical staging | Lymph Node Dissection Number Lymph nodes | Status post Esophagectomy
Item
6. r0 resection and number of lymph nodes dissected ≥15 after esophagectomy
boolean
C0728940 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0242382 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0024204 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0085198 (UMLS CUI [3,2])
Pathological staging
Item
7. pathological stage of t3-4n0-3m0
boolean
C0443276 (UMLS CUI [1])
CT of thorax and abdomen with contrast | PET/CT scan
Item
8. chest and abdominal contrast enhanced ct within 6 weeks prior to registration(pet/ct scan is selective)
boolean
C2317249 (UMLS CUI [1])
C1699633 (UMLS CUI [2])
Supraclavicular lymph nodes Absent | Abdominal lymph nodes Absent | Status post Operative Surgical Procedure
Item
9. without supraclavicular nodes and abdominal regions nodes existed after surgery
boolean
C0229730 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0588058 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Neoadjuvant Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
10. without neo-adjuvant chemotherapy and radiotherapy
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
White Blood Cell Count procedure | Absolute neutrophil count
Item
11. wbc≥ 4.0x109/l ,absolute neutrophil count (anc) ≥ 2.0x109/l
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Platelet Count measurement
Item
12. platelets ≥ 100x109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement | Blood Transfusion Absent
Item
13. 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
14. 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
15. creatinine ≤ 1.5 x upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
16. sign study-specific informed consent prior to study entry
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Esophageal Neoplasms Primary multiple
Item
1. multiple primary esophageal tumors
boolean
C0014859 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
Invasive cancer | 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])
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])
Systemic Chemotherapy | Prior radiation therapy | Pharmacotherapy Targeted
Item
5. prior systemic chemotherapy, prior radiation therapy or prior target drug therapy
boolean
C1883256 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C0013216 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])

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