ID

16813

Description

Celebrex With Preoperative Chemoradiation - Rectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00188565

Link

https://clinicaltrials.gov/show/NCT00188565

Keywords

Versions (1)
  1. 8/8/16 8/8/16 -
Uploaded on

August 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00188565

English

Eligibility Colorectal Neoplasms NCT00188565

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with resectable or potentially resectable adenocarcinoma of the rectum
Description

Adenocarcinoma of rectum Resectable | Adenocarcinoma of rectum Resectable potential

Data type

boolean

Alias
UMLS CUI [1,1]
C0149978
UMLS CUI [1,2]
C1514888
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1514888
UMLS CUI [2,3]
C3245505
clinical stage t2 n1-2 or t3-4 n0-2 (patients who require diverting loop colostomy are eligible)
Description

TNM clinical staging | Loop colostomy - stoma Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0444911
UMLS CUI [2,2]
C0686904
age greater than 18 years, ecog performance status < 2 (appendix, section 13.1)
Description

Age | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy
Description

Adenocarcinoma | Biopsy | Tumor margin Upper Distance from anal verge | Rigid sigmoidoscopy

Data type

boolean

Alias
UMLS CUI [1]
C0001418
UMLS CUI [2]
C0005558
UMLS CUI [3,1]
C1269830
UMLS CUI [3,2]
C1282910
UMLS CUI [3,3]
C1317308
UMLS CUI [4]
C0399626
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
distant metastasis, prior pelvic irradiation, inflammatory bowel disease, medical conditions which preclude radical therapy
Description

distant metastasis | irradiation of pelvis | Inflammatory Bowel Diseases | medical condition Exclusion Radical therapy

Data type

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2]
C0747411
UMLS CUI [3]
C0021390
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C2828389
UMLS CUI [4,3]
C0260176
history of malignancy within five years (except nonmelanoma skin cancer, cin cervix)
Description

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
hypersensitivity to celecoxib, nsaid, sulfonamides or 5-fu
Description

Hypersensitivity celecoxib | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Hypersensitivity Sulfonamides | Hypersensitivity Fluorouracil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0538927
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003211
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0038760
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0016360
significant comorbid illness
Description

Comorbidity Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
history of peptic ulcer disease or nsaid-related gastrointestinal bleeding
Description

Peptic Ulcer | Gastrointestinal Hemorrhage NSAID Related

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C0003211
UMLS CUI [2,3]
C0439849
use of aspirin, other nsaid or coxib in the two weeks prior to study entry
Description

Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C0003211
UMLS CUI [3]
C1257954
neutrophil count <1.5x109/l, platelet count <100x109/l, serum bilirubin >1.25xuln (upper limit of normal), ast/alt >3xuln, serum creatinine >1.25xuln
Description

Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum

Data type

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
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Similar models

Eligibility Colorectal Neoplasms NCT00188565

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of rectum Resectable | Adenocarcinoma of rectum Resectable potential
Item
patients with resectable or potentially resectable adenocarcinoma of the rectum
boolean
C0149978 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0149978 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
C3245505 (UMLS CUI [2,3])
TNM clinical staging | Loop colostomy - stoma Patient need for
Item
clinical stage t2 n1-2 or t3-4 n0-2 (patients who require diverting loop colostomy are eligible)
boolean
C3258246 (UMLS CUI [1])
C0444911 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Age | ECOG performance status
Item
age greater than 18 years, ecog performance status < 2 (appendix, section 13.1)
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Adenocarcinoma | Biopsy | Tumor margin Upper Distance from anal verge | Rigid sigmoidoscopy
Item
biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy
boolean
C0001418 (UMLS CUI [1])
C0005558 (UMLS CUI [2])
C1269830 (UMLS CUI [3,1])
C1282910 (UMLS CUI [3,2])
C1317308 (UMLS CUI [3,3])
C0399626 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
distant metastasis | irradiation of pelvis | Inflammatory Bowel Diseases | medical condition Exclusion Radical therapy
Item
distant metastasis, prior pelvic irradiation, inflammatory bowel disease, medical conditions which preclude radical therapy
boolean
C1269798 (UMLS CUI [1])
C0747411 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
C0260176 (UMLS CUI [4,3])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
history of malignancy within five years (except nonmelanoma skin cancer, cin cervix)
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity celecoxib | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Hypersensitivity Sulfonamides | Hypersensitivity Fluorouracil
Item
hypersensitivity to celecoxib, nsaid, sulfonamides or 5-fu
boolean
C0020517 (UMLS CUI [1,1])
C0538927 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0038760 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0016360 (UMLS CUI [4,2])
Comorbidity Significant
Item
significant comorbid illness
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Peptic Ulcer | Gastrointestinal Hemorrhage NSAID Related
Item
history of peptic ulcer disease or nsaid-related gastrointestinal bleeding
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors
Item
use of aspirin, other nsaid or coxib in the two weeks prior to study entry
boolean
C0004057 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
C1257954 (UMLS CUI [3])
Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum
Item
neutrophil count <1.5x109/l, platelet count <100x109/l, serum bilirubin >1.25xuln (upper limit of normal), ast/alt >3xuln, serum creatinine >1.25xuln
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])
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