Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer

Browse trials for

• Stomach Neoplasms 2,842

Keywords

• Paclitaxel
• S-1
• Oxaliplatin
• Efficiency
• safety

Study arms

• Experimental
  Paclitaxel + S-1 + Oxaliplatin group

  Paclitaxel: 135 mg/m2, iv, 3h, at D1 ; S-1: 40mg twice daily for patients with a body surface area (BSA) \< 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to \< 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week; Oxaliplatin: 85 mg/m2, iv, 2h, at D1.

  Drug: Paclitaxel + S-1 + Oxaliplatin

Interventions

• DrugPaclitaxel + S-1 + Oxaliplatin

  Paclitaxel: 135 mg/m2, iv, 3h, at D1. S-1: S-1: 40mg twice daily for patients with a body surface area (BSA) \< 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to \< 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week. Oxaliplatin: 85 mg/m2, iv, 2h, at D1.

  Also known as: Paclitaxel + S-1 + Oxaliplatin chemotherapy

Primary outcomes

1. Objective response rate(ORR)

   The sum of complete remission (CR) rate and partial remission (PR) rate.

   Time frame: 2 years

Secondary outcomes

1. Progression-free survival(PFS)

   From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

   Time frame: 2 years

2. Overall survival(OS)

   From date of enrollment until the date of death from any cause, assessed up to 60 months

   Time frame: 2 years

3. Disease control rate(DCR)

   The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year

   Time frame: 2 years