Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction
NCT ID: NCT01468389
Last Updated: 2011-11-10
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
PHASE3
300 participants
INTERVENTIONAL
2011-11-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Taxanes or Platinum in combination with Capecitabine
The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.
Capecitabine
900-1000mg/m2 bid, days 1-14, every 3 weeks
chemotherapy followed by capecitabine alone
The patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression.
capecitabine
Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks
Interventions
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Capecitabine
900-1000mg/m2 bid, days 1-14, every 3 weeks
capecitabine
Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks
Eligibility Criteria
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Inclusion Criteria
2. Age≥ 18 years old
3. Histologically confirmed gastric adenocarcinoma
4. Unresectable recurrent or metastatic disease
5. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
6. Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months.
7. Measurable disease according to the RECIST criteria
8. ECOG performance status ≤2
9. Life expectancy of ≥3 month
10. No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
11. ALT and AST≤2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>90,000/mm3, Hb\>8g/dl
Exclusion Criteria
2. Previous systemic therapy for metastatic gastric cancer
3. Inability to take oral medication
4. Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
5. Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
6. Allergic constitution or allergic history to any investigating agents.
7. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
8. Pregnancy or lactation period
9. Any investigational agent within the past 28 days
10. Other previous malignancy within 5 year
11. Pre-existing neuropathy\>grade 1
12. Legal incapacity
18 Years
75 Years
ALL
No
Sponsors
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The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
OTHER
Responsible Party
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Xu jianming
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Principal Investigators
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Xu jianming, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of the Chinese Academy of Military Medical Science
Locations
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307 Hospital of PLA
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AGC001-307PLAH-XJM
Identifier Type: -
Identifier Source: org_study_id