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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT01468389
First received: November 4, 2011
Last updated: November 8, 2011
Last verified: November 2011

November 4, 2011
November 8, 2011
November 2011
January 2013   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01468389 on ClinicalTrials.gov Archive Site
  • Tumor response rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • disease control rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: Capecitabine
    900-1000mg/m2 bid, days 1-14, every 3 weeks
  • 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
  • Active Comparator: Taxanes or Platinum in combination with Capecitabine
    The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.
    Intervention: Drug: Capecitabine
  • 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.
    Intervention: Drug: capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Xu jianming, M.D. 861051128358 jmxu2003@yahoo.com
China
 
NCT01468389
AGC001-307PLAH-XJM
Yes
Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Not Provided
Principal Investigator: Xu jianming, M.D. The Affiliated Hospital of the Chinese Academy of Military Medical Science
Principal Investigator: XU jianming, M.D. The Affiliated Hospital of the Chinese Academy of Military Medical Science
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP