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

Phase 3

• Conditions: Gastric Cancer
• Interventions: Drug: capecitabine

• Registration Number: NCT01468389
• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-11
• Study Start: 2011-11
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-06
• Last Update Submitted: 2011-11-08
• Study First Posted: 2011-11-09
• Last Update Posted: 2011-11-10
• Primary Completion: 2013-01
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taxanes or Platinum in combination with Capecitabine	capecitabine	The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.
chemotherapy followed by capecitabine alone	capecitabine	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.

Primary Outcome Measures

Name	Time	Method
Progression free survival	1 year

Secondary Outcome Measures

Name	Time	Method
Tumor response rate	1 year
disease control rate	1 year
overall survival	3 year
adverse events	3 year

Trial Locations

Locations (1)

307 Hospital of PLA; 🇨🇳 Beijing, Beijing, China