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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

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ClinicalTrials.gov Identifier: NCT01468389
Recruitment Status : Unknown
Verified November 2011 by Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 9, 2011
Last Update Posted : November 10, 2011
Sponsor:
Information provided by (Responsible Party):
Xu jianming, 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Capecitabine Drug: capecitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Tumor response rate [ Time Frame: 1 year ]
  2. disease control rate [ Time Frame: 1 year ]
  3. overall survival [ Time Frame: 3 year ]
  4. adverse events [ Time Frame: 3 year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468389


Contacts
Contact: Xu jianming, M.D. 861051128358 jmxu2003@yahoo.com

Locations
China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China
Contact: Xu jianming, M.D.    86-10-66947176    jmxu2003@yahoo.com   
Contact: Zhao chuanhua    86-10-66947179    chuanhuazhao@163.com   
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
Principal Investigator: Xu jianming, M.D. The Affiliated Hospital of the Chinese Academy of Military Medical Science

Responsible Party: Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT01468389     History of Changes
Other Study ID Numbers: AGC001-307PLAH-XJM
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011

Keywords provided by Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Gastric Cancer
capecitabine
maintenance treatment

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Taxane
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents