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

A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction.

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: capecitabine

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • 307 Hospital of PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Taxanes or Platinum in combination with Capecitabine; The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.	Drug: Capecitabine; 900-1000mg/m2 bid, days 1-14, every 3 weeks
EXPERIMENTAL: 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	3 year
Tumor response rate	1 year
disease control rate	1 year
adverse events	3 year

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ANTICIPATED): January 1, 2013
• Study Completion (ANTICIPATED): June 1, 2013

Study Registration Dates

• First Submitted: November 4, 2011
• First Submitted That Met QC Criteria: November 6, 2011
• First Posted (ESTIMATE): November 9, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 10, 2011
• Last Update Submitted That Met QC Criteria: November 8, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: capecitabine; Gastric Cancer; maintenance treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: AGC001-307PLAH-XJM