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

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

Tracking Information

• First Submitted Date: December 13, 2012
• First Posted Date: February 25, 2013
• Last Update Posted Date: May 6, 2013
• Study Start Date: December 2012
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 22, 2013): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2015
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01798251
• Other Study ID Numbers: CGOG20120101009
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: BAI Yuxian, Harbin Medical University
• Study Sponsor: Harbin Medical University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yuxian BAI, PhD; The tumor hospital of Harbin medical university

• PRS Account: Harbin Medical University
• Verification Date: May 2013