Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
NCT ID: NCT01672333
Last Updated: 2014-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pathological Response
TOX
oxaliplatin 100mg/m2 IV over 2 hours at 1st day docetaxel 50 mg/m2 IV over 1 hour at 1st day capecitabine 625 mg/m2 PO for 14 days
Interventions
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TOX
oxaliplatin 100mg/m2 IV over 2 hours at 1st day docetaxel 50 mg/m2 IV over 1 hour at 1st day capecitabine 625 mg/m2 PO for 14 days
Eligibility Criteria
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Inclusion Criteria
* T3, T4 any N with non metastatic condition
* Age 18 - 70 years
* Performance status 0,1 according to ECOG criteria
* Adequate bone marrow , liver and renal function
* Hemoglobin ≥ 11 g/dl
* Platelets ≥ 100000 / mm3
* Absolute Neutrophil Count ≥ 1500/mm3
* Normal Bilirubin
* Normal Transaminases
* Normal creatinin
* Absence of active co-morbid illness (uncontrolled infection, uncontrolled DM, cardiopulmonary disease)
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Milad Hospital
OTHER
Responsible Party
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Dr Seyed-Hossein Yahyazadeh-Jabari
Director of Clinical Research Center
Principal Investigators
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Bahram Salmanian, M.D.
Role: PRINCIPAL_INVESTIGATOR
Milad Hospital
Locations
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Fayyazbakhsh hospital
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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TOX protocol
Identifier Type: -
Identifier Source: org_study_id
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