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Trial Title:
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
Condition:
Gastric Cancer
Conditions: Official terms:
Adenocarcinoma
Stomach Neoplasms
Capecitabine
Conditions: Keywords:
Gastric Cancer
capecitabine
maintenance treatment
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
900-1000mg/m2 bid, days 1-14, every 3 weeks
Arm group label:
Taxanes or Platinum in combination with Capecitabine
Intervention type:
Drug
Intervention name:
capecitabine
Description:
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
Arm group label:
chemotherapy followed by capecitabine alone
Summary:
The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine
With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric
cancer is effective and safe.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Having signed informed consent
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:
1. Brain metastasis (known or suspected)
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
307 Hospital of PLA
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu jianming, M.D.
Phone:
86-10-66947176
Email:
jmxu2003@yahoo.com
Contact backup:
Last name:
Zhao chuanhua
Phone:
86-10-66947179
Email:
chuanhuazhao@163.com
Start date:
November 2011
Completion date:
June 2013
Lead sponsor:
Agency:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Agency class:
Other
Source:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01468389
