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XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

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ClinicalTrials.gov Identifier: NCT01798251
Recruitment Status : Unknown
Verified May 2013 by BAI Yuxian, Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : February 25, 2013
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
BAI Yuxian, Harbin Medical University

Tracking Information
First Submitted Date  ICMJE December 13, 2012
First Posted Date  ICMJE February 25, 2013
Last Update Posted Date May 6, 2013
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
  • overall survival (OS) [ Time Frame: from the date of randomization until death from any cause or up to 1 year ]
  • Response Rate (RR) [ Time Frame: evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks ]
  • adverse events (AE) [ Time Frame: from date of randomization to 28 days after the last chemo dosage ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 3, 2013)
  • health-related quality of life (HRQOL) [ Time Frame: evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage ]
  • excision repair cross-complementing 1(ERCC1) expression [ Time Frame: assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment ]
    quantitative real-time reverse transcriptase polymerase chain reaction (PCR) assays were performed to determine ERCC1 mRNA expression in tumor tissue.
  • K-ras gene type [ Time Frame: assess after randomization and before the first treatment ]
    Genomic Deoxyribonucleic acid (DNA) is extracted from tumor tissue, direct sequencing technique is used to test K-ras gene type(mutation or wild).
Original Other Pre-specified Outcome Measures
 (submitted: February 22, 2013)
health-related quality of life (HRQOL) [ Time Frame: evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage ]
 
Descriptive Information
Brief Title  ICMJE XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach
Official Title  ICMJE A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach
Brief Summary To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.
Detailed Description To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Drug: Oxaliplatin
    Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
    Other Name: L-OHP
  • Drug: Capecitabine
    capecitabine 850mg/m2 bid, d1-14, every 3 weeks
    Other Name: XELODA
Study Arms  ICMJE
  • Experimental: XELOX-X

    XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance.

    X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance.

    Interventions:
    • Drug: Oxaliplatin
    • Drug: Capecitabine
  • Active Comparator: XELOX
    XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 22, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages Eligible for Study: 65 Years or older
  • Genders Eligible for Study: Both
  • The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
  • Histologically confirmed gastric adenocarcinoma(including LAUREN type).
  • Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
  • chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
  • Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.
  • No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
  • Able to accept oral medication
  • Compliance with protocol

Exclusion Criteria:

  • Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
  • Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
  • Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
  • clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
  • Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
  • Organ transplantation requires immunosuppressive treatment.
  • Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
  • Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.
  • Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
  • Allergy to Oxaliplatin or any study medication ingredients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01798251
Other Study ID Numbers  ICMJE CGOG20120101009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BAI Yuxian, Harbin Medical University
Study Sponsor  ICMJE Harbin Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuxian BAI, PhD The tumor hospital of Harbin medical university
PRS Account Harbin Medical University
Verification Date May 2013

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