Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
NCT ID: NCT02289378
Last Updated: 2014-11-14
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
30 participants
INTERVENTIONAL
2014-11-30
2017-10-31
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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Docetaxel, Oxaliplatin and 5-Fu
Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks
Docetaxel, Oxaliplatin and 5-Fu
To investigate the triplet regimen in the first-line therapy of advanced chemotherapy
Interventions
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Docetaxel, Oxaliplatin and 5-Fu
To investigate the triplet regimen in the first-line therapy of advanced chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2
* Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
* At least 3 weeks since last major surgery
* At least 12 months since last adjuvant chemotherapy
* At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected
* Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields
* Patients with reproductive potential must use effective BC
* Required Screening Laboratory Criteria:
Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min
* A probable life expectancy of at least 6 months
Exclusion Criteria
* Female of childbearing potential, pregnancy test is positive
* Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer
* Active infection
* Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
* Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator
* History of grade 3 or 4 toxicity to fluoropyrimidines
18 Years
75 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Lan Ping
Professor
Principal Investigators
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Ping Lan, MD
Role: STUDY_CHAIR
The Sixth Affilated Hospital of Sun Yat-sen University
Locations
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The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DaeMon Plus
Identifier Type: -
Identifier Source: org_study_id