Eligibility Esophageal Squamous Cell Carcinoma NCT01391572

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

Eligibility Esophageal Squamous Cell Carcinoma NCT01391572

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])