Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
Phase 3
- Conditions
- Advanced Gastric Cancer
- Interventions
- Registration Number
- NCT01015339
- Lead Sponsor
- Peking University
- Brief Summary
The purpose of this study is to investigate whether Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
- Unresectable recurrent or metastatic disease
- Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
- Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.
- Measurable disease according to the RECIST criteria
- Karnofsky performance status ≥60
- Life expectancy of ≥2 month
- No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
- ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
- Serum albumin level ≥3.0g/dL
- Serum AKP < 2.5 times ULN
- Serum creatinine <ULN, and CCr < 60ml/min
- Bilirubin level < 1.5 ULN
- WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl
Exclusion Criteria
- Brain metastasis (known or suspected)
- Previous systemic therapy for metastatic gastric cancer
- Inability to take oral medication
- Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
- Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
- Allergic constitution or allergic history to protium biologic product or any investigating agents.
- 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.
- Pregnancy or lactation period
- Any investigational agent within the past 28 days
- Other previous malignancy within 5 year, except non-melanoma skin cancer
- Previous adjuvant therapy with capecitabine+platinum,
- Pre-existing neuropathy>grade 1
- Legal incapacity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel plus Capecitabine capecitabine - Cisplatin plus capecitabine cisplatin - Cisplatin plus capecitabine capecitabine - Paclitaxel plus Capecitabine Paclitaxel -
- Primary Outcome Measures
Name Time Method Progression free survival 3 year
- Secondary Outcome Measures
Name Time Method Disease control rate 1 year Overall survival 5 year Tumor response rate 1 year adverse evens 5 year
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie paclitaxel and capecitabine synergy in advanced gastric cancer?
How does paclitaxel plus capecitabine compare to cisplatin plus capecitabine in metastatic adenocarcinoma of the stomach?
Which biomarkers predict response to capecitabine maintenance therapy in HER2-negative gastric cancer?
What are the key adverse events associated with paclitaxel-based regimens in metastatic adenocarcinoma of the esophagogastric junction?
How do tyrosine kinase inhibitors compare to paclitaxel in combination with capecitabine for first-line treatment of advanced gastric cancer?
Trial Locations
- Locations (1)
Department of GI Oncology, Peking University, School of Oncology
🇨🇳Beijing, Beijing, China
Department of GI Oncology, Peking University, School of Oncology🇨🇳Beijing, Beijing, ChinaZhihao Lu, MDContact86-10-88196561pppeirain@126.comShen Lin, MDPrincipal Investigator