Clinical Trials /

Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer

NCT02289547

Description:

XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by maintenance Capecitabine or Observation in the gastric cancer patients of stable disease after 6 cycle 1st line of XELOX chemotherapy .

Related Conditions:
  • Gastric Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer
  • Official Title: Randomized Phase 3 Study of Xelox(Capecitabine Plus Oxaliplatin) Followed by Maintenance Capecitabine or Observation in Patients With Advanced Gastric Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: CMCGA1 Trial
  • NCT ID: NCT02289547

Conditions

  • Stomach Neoplasms

Interventions

DrugSynonymsArms
CapecitabineXelodaGroup B

Purpose

XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by maintenance Capecitabine or Observation in the gastric cancer patients of stable disease after 6 cycle 1st line of XELOX chemotherapy .

Detailed Description

      Study rationale : Park et al. observed the oxaliplatin as part of XELOX regimen had a more
      favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer.
      The safety profile of oxaliplatin makes it an ideal candidate for combination therapy.
      However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. The
      response with XELOX regimen generally occurs earlier. It may therefore be possible to devise
      capecitabine maintenance regimen which achieves maximum treatment effect before cumulative
      neurotoxicity appears. This regimen was studied in colon and breast cancer.

      - Objective: Primary: To evaluate progression free survival Secondary: To evaluated overall
      survival, response rate, toxicity profile of chemotherapy, quality of life

        -  Design :Multicenter randomized controlled phase III open label trial Study subjects will
           be randomized to two groups in a ratio of 1:1 Subjects More than stable disease after 6
           cycle 1st line of XELOX chemotherapy (OR non-complete response/non-progressive disease
           in cases of non-measurable disease before XELOX chemotherapy),

        -  Treatment Groups Group A : Capecitabine: Capecitabine 1000mg/m2 bid D1-14, q 3 week
           Group B : Observation

        -  Evaluation of response and toxicity A response will be evaluated radiologically every
           two cycles thereafter, or when progression is suspicious by RECIST criteria version 1.1.

      A progression-free survival is defined as the time from the date of randomization to the date
      of first documented disease progression or death due to any cause.

      An overall survival is defined as the time from the 1stdate of chemotherapy to the date of
      death.

      Safety will be evaluated every treatment by NCI-CTCAE version 4.0.
    

Trial Arms

NameTypeDescriptionInterventions
Group ANo Interventionobservational arm
    Group BExperimentalarm of capecitabine maintenance treatment
    • Capecitabine

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically proven gastric cancer
    
              -  Minimum age of 18 years
    
              -  Stage IV (regardless of the presence or absence of measurable disease by RECIST
                 criteria) or recurrent after curative surgery
    
              -  Negative expression (0, 1) of Her2 Immuno-histochemistry or negative amplification of
                 FISH in Her2 Immuno-histochemistry 2+
    
              -  More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-Complete
                 response/non-Progressive disease in cases of non-measurable disease before XELOX
                 chemotherapy)
    
              -  Eastern Cooperative Oncology Group Performance status 0-2
    
              -  Adequate bone marrow function: Absolute neutrophil count ≥ 1,500/ul, Hemoglobin ≥ 8
                 g/dL, platelet ≥ 100,000/μl
    
              -  Adequate renal function: Serum creatinine ≤ 1.5 x ULN (upper normal limit) or
                 creatinine clearance ≥ 60 ml/min
    
              -  Adequate hepatic function: serum bilirubin ≤ 2.5 x UNL, AST and ALT ≤ 2.5 x UNL (≤ 5 x
                 ULN in the presence of liver metastasis)
    
              -  Patients must sign an informed consent indicating that they are aware of the
                 investigational nature of the study in keeping with the policy of the hospital
    
            Exclusion Criteria:
    
              -  Patients who were exposed previously to any chemotherapy except XELOX for advanced
                 disease
    
              -  Patients who received R0 or R1 resection for metastatic or recurrent gastric cancer
                 and without evaluable/measurable disease
    
              -  Disease relapsed during or within 4 months after adjuvant therapy
    
              -  Patients who had central nervous system and meningeal metastases
    
              -  Patients with significant neurologic or psychiatric disorders
    
              -  Patients with active infection, severe heart disease, uncontrollable hypertension or
                 diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or
                 breast feeding
    
              -  Any previous or concurrent malignancy except for adequately treated non-melanoma skin
                 cancer, in situ cancer of uterine cervix, non-muscle invasive bladder cancer or
                 malignancy without evidence of recurrence within 5 years
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression free survival
    Time Frame:From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
    Safety Issue:
    Description:every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression

    Secondary Outcome Measures

    Measure:Overall survival
    Time Frame:From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
    Safety Issue:
    Description:every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until death
    Measure:quality of life in patients measured by QLQ-c30 and STO-22
    Time Frame:From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
    Safety Issue:
    Description:every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
    Measure:Toxicity profile of each patients measured by NCI-CTCAE ver 4.0
    Time Frame:From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
    Safety Issue:
    Description:every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:The Catholic University of Korea

    Trial Keywords

    • chemotherapy
    • stomach neoplasms

    Last Updated