A Randomized, Multicenter, Controlled, Adaptive II/III Study to Compare Neoadjuvant Chemotherapy of Docetaxel，Oxaliplatin Combined With S-1(DOS) Versus Oxaliplatin Combined With S-1(SOX)in Locally Advanced Gastric Adenocarcinoma (RESOLVE-2 Study)
Overview
- Phase
- Phase 2
- Intervention
- Docetaxel
- Conditions
- Gastric Adenocarcinoma
- Sponsor
- Peking University
- Enrollment
- 258
- Locations
- 1
- Primary Endpoint
- The rate of pathologic complete response（pCR%）
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy of Docetaxel，Oxaliplatin combined with S-1(DOS) versus Oxaliplatin combined with S-1(SOX) in locally advanced gastric adenocarcinoma
Detailed Description
This trial is conducted in patients with locally advanced gastric adenocarcinoma. Eligible patients are randomized into two arms at 1:1 ratio to receive Docetaxel, Oxaliplatin combined with S-1(DOS) for 4 cycles or Oxaliplatin combined with S-1(SOX) for 3 cycles as neoadjuvant chemotherapy. All eligible patients will receive D2 gastrectomy if possible. Then, all eligible patients will also received DOS for 4 cycles or SOX for 3 cycles within 8 weeks after surgery. Study evaluation time is until death of patients or deadline set by the researchers.
Investigators
Shen Lin
Head of Beijing Cancer Hospital
Peking University
Eligibility Criteria
Inclusion Criteria
- •Ambulatory males or females with ages ≥
- •Karnofsky performance status ≥ 70%.
- •Histologically confirmed gastric adenocarcinoma including Lauren classification and validated overexpression of HER
- •cTNM should be diagnosed by enhanced CT/MRI (combined with endoscopic ultrasonography and diagnostic laparoscopic exploration) as cIII/IVa according to AJCC 8th classification.
- •Radical resection is possible before operation.
- •Research center and surgeons have the ability of conducting D2 lymphadenectomy (more than 15 lymph glands should be checked to ensure the quality of operation).
- •Physiological status and organ function are acceptable for major abdominal surgical operation.
- •Baseline blood routine and biochemical indexes of patients enrolled should meet criteria below: hemoglobin ≥ 90g/L, absolute neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 100×10⁹/L, aspartate or alanine aminotransferase ≤ 2.5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the ULN, total serum bilirubin \< 1.5 times the ULN, serum creatinine \< 1 time ULN, Serum albumin ≥ 30g/L.
- •Left ventricular ejection fraction evaluated by echocardiac scanning ≥ 50%.
- •No severe comorbidity with less than 5 year survival.
Exclusion Criteria
- Not provided
Arms & Interventions
DOS
Docetaxel+Oxaliplatin+S-1
Intervention: Docetaxel
SOX
Oxaliplatin+S-1
Intervention: Oxaliplatin
Outcomes
Primary Outcomes
The rate of pathologic complete response（pCR%）
Time Frame: 1 year
Evaluation of pCR% of DOS regimen versus SOX regimen in locally advanced gastric adenocarcinoma
Secondary Outcomes
- Overall Survival : From date of enrollment until the date of death(5 years)
- Progression-free Survival：From date of enrollment until the date of first documented progression or second gastric cancer or death from any cause, whichever came first.(3 years)