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

November 8, 2011 updated by: Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGC001-307PLAH-XJM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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