Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one chemotherapy drug with surgery may kill
      more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective
      than surgery followed by chemotherapy for stomach cancer.

      PURPOSE: This randomized phase III trial is studying surgery followed by combination
      chemotherapy to see how well it works compared to combination chemotherapy followed by
      surgery in treating patients with locally advanced stomach cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of
           docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in
           patients with locally advanced operable gastric carcinoma.

        -  Evaluate the predictive values of some biological and molecular tumor parameters on
           response to chemotherapy, metastasis and survival in this patient population.

      OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
      according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and
      III) vs rest of the stomach), and nodal status (positive vs negative). Patients are
      randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery
      followed by postoperative chemotherapy (arm II).

        -  Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours
           on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are
           evaluated after 2 courses and patients with progressive disease proceed to immediate
           surgery. Otherwise, treatment continues for a total of 4 courses in the absence of
           unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the
           last course of chemotherapy, patients undergo gastric resection.

        -  Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery,
           patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.

      Quality of life is assessed before the first and third courses of chemotherapy, before and
      after surgery, and then at 1, 3, and 6 months.

      Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.
    

Intervention name(s): Taxotere-Cisplatin-5FU; Immediate surgery
Intervention type(s): Drug; Drug
Intervention description(s): Preoperatively; Immediate surgery followed by Taxotere-Cisplatin-5FU
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II gastric cancer; stage III gastric cancer