TOF Versus SOX in Metastatic Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study was designed to compare the efficacy and safety of
      aclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen for
      metastatic gastric cancer (GC) patients.
    

Detailed description: 
      Gastric carcinoma ranks second among the most common causes of cancer deaths worldwide, with
      especial high prevalence in Asia . Gastric cancer is the third most common cancer in China
      and the incidence rate and death rate of gastric cancer in Jiangsu Province are especially
      higher than the national average. Surgical resection is the preferred treatment for gastric
      cancer, but approximately two-thirds of patients have metastatic disease at the time of
      diagnosis. Prognosis in these patients is poor, with a median survival time of 3 to 5 months
      without treatment and a reported 5-year survival rate of 9.4%. Even receiving curative
      gastrectomy, 60% of mGC patients develop local recurrences or distant metastasis.

      For advanced-stage patients with inoperable gastric tumors, chemotherapy is considered the
      most effective treatment option and the efficacy of postoperative chemotherapy has been
      acknowledged. However, a worldwide consensus on standard chemotherapy regimens has yet to be
      established. The prognosis has gradually improved because of advances in chemotherapy
      regimens, but is not yet satisfactory.Among various regimens, the combinations of
      paclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen have
      become two important ones.

      Paclitaxel can bind to microtubules and induces hyperstabilization leading to cell cycle
      arrest and apoptosis. The response rate of GC patients to paclitaxel is 20%-25%. Oxaliplatin
      is a third-generation diaminocyclohexane platinum compound which has a wide range of
      antitumor activities, appearing to have a better safety profile than cisplatin. The response
      rate of mGC patients to FOLFOX-4 regimen is 38%-43%. S-1 is an oral anti-cancer agent
      composed of tegafur, 5-chloro-2,4-dihydroxypyridine, and oteracil potassium. The applying of
      S-1 as adjuvant chemotherapy for mGC can improve the overall survival (OS) and relapse-free
      survival. A meta-analysis showed OS favored S-1-based chemotherapy over 5-FU-based
      chemotherapy in mGC. S-1 plus oxaliplatin (SOX) have showed non-inferiority to S-1 plus
      cisplatin in PFS and that the treatment was well tolerated in patients with mGC.

      No study is available comparing the efficacy and safety of TOF and SOX regimens. So the
      investigators performed the present randomized, controlled study to compare the efficacy and
      safety of the two regimens in mGC patients.
    

Intervention name(s): paclitaxel+oxaliplatin+fluorouracil; oxaliplatin+S1
Intervention type(s): Drug; Drug
Intervention description(s): Patients treated with "paclitaxel+oxaliplatin+fluorouracil": paclitaxel (135 mg/m2 iv) on day 1, oxaliplatin (100 mg/m2 iv) on day 1, fluorouracil (500 mg/m2 continuous iv) on day 1-5twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14.; Patients treated with "oxaliplatin+S1": oxaliplatin (130 mg/m2 iv) on day 1 and S-1 (40 mg twice/day for body surface area < 1.25 m2 and 60 mg twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14
Other intervention name(s): TOF regimen; SOX regimen
Intervention MeSH terms: Paclitaxel; Fluorouracil; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment