A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC
NCT ID: NCT01963702
Last Updated: 2013-10-16
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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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2012-08-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Docetaxol ＆Capecitabine (TX)
Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
Docetaxol
Capecitabine
Oxaliplatin ＆Capecitabine (XELOX)
Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
Oxaliplatin
Capecitabine
Interventions
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Docetaxol
Oxaliplatin
Capecitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must have at least one measurable lesions (RECIST 1.1)
* 18 Years to 75 years
* Written informed consent obtained
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients must have adequate organ and marrow function as defined below:
* neutrophilicgranulocyte greater than/equal to 1,500/mm3;
* platelets greater than/equal to 90,000/ mm3;
* hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);
* total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
* Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN
* serum creatinine less than/equal to 1.5 x IULN.
Exclusion Criteria
* Symptomatic metastatic brain or meningeal tumors
* History of organ allograft
* Patients undergoing renal dialysis
* chronic inflammatory bowel disease; ileus; genetic fructose intolerance
* Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months
* Receive previously radiotherapy in measurable regions
* Pregnancy or lactating status
* Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma
* Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
* Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
* Any factors that influence the usage of oral administration
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xiaodong Zhu
associate professor
Principal Investigators
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Jin Li, M.D / Ph.D
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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xiaodong Zhu, M.D
Role: primary
Other Identifiers
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FDZL-TXELOX
Identifier Type: -
Identifier Source: org_study_id