Eligibility Esophageal Squamous Cell Carcinoma NCT01402180

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

Eligibility Esophageal Squamous Cell Carcinoma NCT01402180

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