Information:
Fel:
ID
17392
Beskrivning
Celecoxib/Oxaliplatin/Capecitabine for Gastric/GE Junction Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00256321
Länk
https://clinicaltrials.gov/show/NCT00256321
Nyckelord
Versioner (1)
- 2016-09-11 2016-09-11 -
Uppladdad den
11 september 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Gastric Carcinoma NCT00256321
Eligibility Gastric Carcinoma NCT00256321
- StudyEvent: Eligibility
Similar models
Eligibility Gastric Carcinoma NCT00256321
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Stomach Carcinoma unresectable | recurrent gastric cancer | Stomach Carcinoma Metastatic | Gastrooesophageal cancer unresectable | Gastrooesophageal cancer Recurrent | Gastrooesophageal cancer Metastatic | Gastric lymphoma | Gastrointestinal Stromal Tumors | Unstained Specimen Paraffin Embedding | COX-2 Expression Analysis
Item
patient must have histologically proven, pathologically verified and surgically incurable(unresectable, recurrent, or metastatic) gastric/gastroesophageal junction carcinoma. gastric lymphoma and gastrointestinal stromal tumor(gist) are ineligible for this study. at least 6 unstained paraffin-embedded pathologic specimen slides will be required for the cox-2 expression assays.
boolean
C0699791 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0278502 (UMLS CUI [2])
C0699791 (UMLS CUI [3,1])
C0036525 (UMLS CUI [3,2])
C1112160 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C1112160 (UMLS CUI [5,1])
C2945760 (UMLS CUI [5,2])
C1112160 (UMLS CUI [6,1])
C0036525 (UMLS CUI [6,2])
C0349532 (UMLS CUI [7])
C0238198 (UMLS CUI [8])
C1883469 (UMLS CUI [9,1])
C0085185 (UMLS CUI [9,2])
C2827630 (UMLS CUI [10])
C1519810 (UMLS CUI [1,2])
C0278502 (UMLS CUI [2])
C0699791 (UMLS CUI [3,1])
C0036525 (UMLS CUI [3,2])
C1112160 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C1112160 (UMLS CUI [5,1])
C2945760 (UMLS CUI [5,2])
C1112160 (UMLS CUI [6,1])
C0036525 (UMLS CUI [6,2])
C0349532 (UMLS CUI [7])
C0238198 (UMLS CUI [8])
C1883469 (UMLS CUI [9,1])
C0085185 (UMLS CUI [9,2])
C2827630 (UMLS CUI [10])
2-Dimensional Measurable Disease | Physical Examination | X-Ray Computed Tomography | Radionuclide Imaging | Plain x-ray
Item
patient must have bidimensionally measurable disease as defined in section 10.1a. all measurable lesions must be assessed (by physical examination, ct scan, radionuclide scan or plain x-ray) within 30 days prior to registration. the patient's disease status must be completely assessed and reported.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0034606 (UMLS CUI [4])
C1306645 (UMLS CUI [5])
C1705052 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0034606 (UMLS CUI [4])
C1306645 (UMLS CUI [5])
CT of abdomen | Chest CT
Item
all patients must undergo a ct of abdomen and chest within 30 days prior to registration.
boolean
C0412620 (UMLS CUI [1])
C0202823 (UMLS CUI [2])
C0202823 (UMLS CUI [2])
Metastatic malignant neoplasm to brain | brain ct | brain MRI | Neurologic Symptoms | Secondary malignant neoplasm of lung | Radiography | Brain MRI W contrast IV
Item
patients with brain metastases are not eligible for this study. it is not mandatory to obtain brain ct or mri on all patients. however, patients who exhibit neurological symptoms or have pulmonary metastases on radiographic studies must obtain brain ct w/ iv contrast or mri prior to registration to ascertain the presence of brain metastasis.
boolean
C0220650 (UMLS CUI [1])
C0412585 (UMLS CUI [2])
C0412675 (UMLS CUI [3])
C0235031 (UMLS CUI [4])
C0153676 (UMLS CUI [5])
C0034571 (UMLS CUI [6])
C0881826 (UMLS CUI [7])
C0412585 (UMLS CUI [2])
C0412675 (UMLS CUI [3])
C0235031 (UMLS CUI [4])
C0153676 (UMLS CUI [5])
C0034571 (UMLS CUI [6])
C0881826 (UMLS CUI [7])
capecitabine | oxaliplatin | Cisplatin | Carboplatin | Fluorouracil | systemic therapy Completed
Item
patients must not have received capecitabine or oxaliplatin. prior use of cisplatin, carboplatin, 5-fu are permitted. prior systemic therapy must have been completed at least 30 days before registration.
boolean
C0671970 (UMLS CUI [1])
C0069717 (UMLS CUI [2])
C0008838 (UMLS CUI [3])
C0079083 (UMLS CUI [4])
C0016360 (UMLS CUI [5])
C1515119 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
C0069717 (UMLS CUI [2])
C0008838 (UMLS CUI [3])
C0079083 (UMLS CUI [4])
C0016360 (UMLS CUI [5])
C1515119 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
Therapeutic radiology procedure Completed
Item
patients may have received prior radiation therapy. radiation therapy must have been completed at least 30 days before registration.
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
Operative Surgical Procedure Completed
Item
patients may have received prior surgery. prior surgery must have been completed at least 30 days before registration.
boolean
C0543467 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
Zubrod Performance Status
Item
patients must have a zubrod performance status of 0-2.
boolean
C3714786 (UMLS CUI [1])
Pregnancy | Breast Feeding | Urine pregnancy test
Item
pregnant or nursing women are not eligible to participate in this trial because the safe use of these drugs in pregnancy have not been established. urine pregnancy test must be done prior to the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430056 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0430056 (UMLS CUI [3])
Allergic Reaction Sulfonamides
Item
patient must not have known allergic reaction to sulfonamides
boolean
C1527304 (UMLS CUI [1,1])
C0038760 (UMLS CUI [1,2])
C0038760 (UMLS CUI [1,2])
Allergic Reaction celecoxib | Adverse reactions celecoxib
Item
patient must not have known allergic or other adverse reaction to celecoxib
boolean
C1527304 (UMLS CUI [1,1])
C0538927 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0538927 (UMLS CUI [2,2])
C0538927 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0538927 (UMLS CUI [2,2])
Peripheral Neuropathy persistent
Item
patient must not have persistent peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,2])
Hypersensitivity Fluorouracil | Hypersensitivity Platinum
Item
patient must not have known hypersensitivity reactions to 5-fu or platinum
boolean
C0020517 (UMLS CUI [1,1])
C0016360 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0206135 (UMLS CUI [2,2])
C0016360 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0206135 (UMLS CUI [2,2])
Gastric hemorrhage | Duodenal hemorrhage
Item
patient must not have active gastric/duodenal bleeding
boolean
C0235325 (UMLS CUI [1])
C0521595 (UMLS CUI [2])
C0521595 (UMLS CUI [2])
Hypersensitivity Aspirin | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Asthma | Urticaria | Allergic Reaction Aspirin | Allergic Reaction Anti-Inflammatory Agents, Non-Steroidal
Item
patient must not have had a sensitivity reaction to aspirin or other nsaids [experiencing asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids]
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0004096 (UMLS CUI [3])
C0042109 (UMLS CUI [4])
C1527304 (UMLS CUI [5,1])
C0004057 (UMLS CUI [5,2])
C1527304 (UMLS CUI [6,1])
C0003211 (UMLS CUI [6,2])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0004096 (UMLS CUI [3])
C0042109 (UMLS CUI [4])
C1527304 (UMLS CUI [5,1])
C0004057 (UMLS CUI [5,2])
C1527304 (UMLS CUI [6,1])
C0003211 (UMLS CUI [6,2])
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