Overall Survival of Inoperable Gastric/GastroOesophageal Cancer Subjects on Treating With LMWH + Chemotherapy(CT) vs Standard CT
Condition: Gastric Cancer; Gastroesophageal Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Due to evidence available both in terms of efficacy and safety of low molecular weight
      heparin, its use for the prevention of thromboembolic disease in cancer patients undergoing
      surgical intervention, and its extended use in higher doses for the prevention of recurrent
      thromboembolism in cancer patients with established thrombosis, with a view that the
      potential benefits for survival in cancer patients from low molecular weight heparin therapy
      comes because of a biological activity, the dose of 1mg/Kg (50% of the full treatment dose)
      for a period of 6 months coincident with 6 cycles of chemotherapy, has been chosen for this
      study.
    

Detailed description: 
      In the GASTRANOX study, patients will have inoperable (locally advanced) or metastatic newly
      diagnosed gastric or gastro oesophageal cancer. These patients carry a definite thrombosis
      risk. Patients will be scheduled to have at least 6 months of palliative chemotherapy. During
      this period symptomatic thromboembolism will be common but currently no routine prophylaxis
      is provided.

      The dose of Enoxaparin to be evaluated in this study is 1mg/kg. This represents half of the
      full treatment dose. For an average weight individual this will represent between 60 and 70
      mg a day of Enoxaparin. The prophylactic dose for high-risk surgical patients in the United
      States is 60mg total daily dosing of Enoxaparin per day. This high-risk dose has been shown
      to be safe and effective in preventing thromboembolic disease in high-risk populations such
      as those undergoing major elective orthopaedic surgery. An alternative for high-risk dose is
      40mg given once a day. This dose is also effective and safe. Thus the dose to be provided in
      the GASTRANOX study is not markedly different from the high-risk doses already in routine
      clinical practice either in North America (30mg twice a day - 60mg total daily dosing) or
      40mg once a day in Europe. It is also half of the full treatment dose which has been shown to
      be effective and safe in the treatment of venous thromboembolism.

      Since cancer patients are recognised to have bleeding risk it was felt inappropriate to
      provide the full treatment dose of Enoxaparin. Thus half the full treatment doses provided.
      On the other hand the biological effect of low molecular weight heparins in cancer suggests
      that higher doses be given to enhance the potential survival benefit.

      The study is intended to evaluate the safety and efficacy of the study drug compared to best
      normal practice. The standard methodology for such a comparison is to conduct a randomized,
      comparative study.

      Multi-centre: It is anticipated that a single centre will be unable to recruit sufficient
      subjects, in 1 year, to conduct the assessment and therefore multiple centres will be
      recruited to conduct the study.

      Open Label: All patients will receive standard care at their site. It would not be feasible
      to expect placebo parenteral administration for six months. All VTE events will be
      adjudicated. Mortality is an objective end-point.

      Standard treatment control: subjects will be treated according to best practice with half
      also receiving the study treatment.

      Parallel-group: due to the nature of the condition this is the only practical design.
    

Intervention name(s): Enoxaparin; Standard Chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Once daily dose of 1mg/Kg of body weight for 6 months; Investigator's discretion
Other intervention name(s): Some commonly prescribed Chemotherapy regimens in India are:; - Epirubicin + Cisplatin + Capecitabine; - Capecitabine + Oxaliplatin; - Docetaxil + Carboplatin; - Epirubicin + Cisplatin + Fluorouracil; - Docetaxil + Cisplatin with G/C/S/F support; - Epirubicin + Cisplatin + Flourouracil; - Docetaxil + Cisplatin + Flourouracil
Intervention MeSH terms: Cisplatin; Carboplatin; Capecitabine; Fluorouracil; Oxaliplatin; Epirubicin; Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bleeding events