ID

17392

Description

Celecoxib/Oxaliplatin/Capecitabine for Gastric/GE Junction Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00256321

Link

https://clinicaltrials.gov/show/NCT00256321

Keywords

Versions (1)
  1. 9/11/16 9/11/16 -
Uploaded on

September 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Gastric Carcinoma NCT00256321

English

Eligibility Gastric Carcinoma NCT00256321

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0699791
UMLS CUI [1,2]
C1519810
UMLS CUI [2]
C0278502
UMLS CUI [3,1]
C0699791
UMLS CUI [3,2]
C0036525
UMLS CUI [4,1]
C1112160
UMLS CUI [4,2]
C1519810
UMLS CUI [5,1]
C1112160
UMLS CUI [5,2]
C2945760
UMLS CUI [6,1]
C1112160
UMLS CUI [6,2]
C0036525
UMLS CUI [7]
C0349532
UMLS CUI [8]
C0238198
UMLS CUI [9,1]
C1883469
UMLS CUI [9,2]
C0085185
UMLS CUI [10]
C2827630
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.
Description

2-Dimensional Measurable Disease | Physical Examination | X-Ray Computed Tomography | Radionuclide Imaging | Plain x-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0034606
UMLS CUI [5]
C1306645
all patients must undergo a ct of abdomen and chest within 30 days prior to registration.
Description

CT of abdomen | Chest CT

Data type

boolean

Alias
UMLS CUI [1]
C0412620
UMLS CUI [2]
C0202823
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.
Description

Metastatic malignant neoplasm to brain | brain ct | brain MRI | Neurologic Symptoms | Secondary malignant neoplasm of lung | Radiography | Brain MRI W contrast IV

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0412585
UMLS CUI [3]
C0412675
UMLS CUI [4]
C0235031
UMLS CUI [5]
C0153676
UMLS CUI [6]
C0034571
UMLS CUI [7]
C0881826
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.
Description

capecitabine | oxaliplatin | Cisplatin | Carboplatin | Fluorouracil | systemic therapy Completed

Data type

boolean

Alias
UMLS CUI [1]
C0671970
UMLS CUI [2]
C0069717
UMLS CUI [3]
C0008838
UMLS CUI [4]
C0079083
UMLS CUI [5]
C0016360
UMLS CUI [6,1]
C1515119
UMLS CUI [6,2]
C0205197
patients may have received prior radiation therapy. radiation therapy must have been completed at least 30 days before registration.
Description

Therapeutic radiology procedure Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
patients may have received prior surgery. prior surgery must have been completed at least 30 days before registration.
Description

Operative Surgical Procedure Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205197
patients must have a zubrod performance status of 0-2.
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
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.
Description

Pregnancy | Breast Feeding | Urine pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430056
patient must not have known allergic reaction to sulfonamides
Description

Allergic Reaction Sulfonamides

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0038760
patient must not have known allergic or other adverse reaction to celecoxib
Description

Allergic Reaction celecoxib | Adverse reactions celecoxib

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0538927
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0538927
patient must not have persistent peripheral neuropathy
Description

Peripheral Neuropathy persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0205322
patient must not have known hypersensitivity reactions to 5-fu or platinum
Description

Hypersensitivity Fluorouracil | Hypersensitivity Platinum

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016360
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0206135
patient must not have active gastric/duodenal bleeding
Description

Gastric hemorrhage | Duodenal hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0235325
UMLS CUI [2]
C0521595
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]
Description

Hypersensitivity Aspirin | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Asthma | Urticaria | Allergic Reaction Aspirin | Allergic Reaction Anti-Inflammatory Agents, Non-Steroidal

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003211
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0042109
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0004057
UMLS CUI [6,1]
C1527304
UMLS CUI [6,2]
C0003211
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Similar models

Eligibility Gastric Carcinoma NCT00256321

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
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])
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])
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])
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])
Allergic Reaction Sulfonamides
Item
patient must not have known allergic reaction to sulfonamides
boolean
C1527304 (UMLS CUI [1,1])
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])
Peripheral Neuropathy persistent
Item
patient must not have persistent peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
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])
Gastric hemorrhage | Duodenal hemorrhage
Item
patient must not have active gastric/duodenal bleeding
boolean
C0235325 (UMLS CUI [1])
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])
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