XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,024
- 试验地点
- 11
- 主要终点
- DFS
研究概览
简要总结
Our study aims to compare 4 months versus 6 months of adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in patients with gastric cancer.
Hypothesis: We hypothesize that a 4-month regimen of capecitabine plus oxaliplatin is noninferior to a 6-month regimen with respect to DFS and is associated with lower treatment-related toxicity.
详细描述
Surgical resection is the cornerstone of treatment for patients with localized gastric cancer. In the CLASSIC trial, capecitabine plus oxaliplatin for 6 months following D2 gastrectomy has been established as a standard postoperative adjuvant treatment for patients with operable stage II or III gastric cancer. However, due to adverse events, chemotherapy was discontinued in 50 patients (10%), primarily due to nausea, neutropenia, decreased appetite, peripheral neuropathy, diarrhea, and vomiting. At the 2017 ASCO Annual Meeting, Grothey et al. reported the results of the IDEA trial. For patients with lymph node-positive colon cancer (stage III), some patients may benefit from a shorter duration of postoperative chemotherapy. An analysis of six clinical trials involving over 12,800 patients showed that 3 months of chemotherapy was nearly as effective as 6 months for patients with a lower recurrence risk, while also causing fewer side effects, particularly nerve damage. Based on the findings from the IDEA trial, we hypothesize that a 4-month regimen of capecitabine plus oxaliplatin may also benefit patients following D2 gastrectomy while reducing adverse events compared with the standard 6-month regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, staged as II, IIIA, or IIIB according to the American Joint Committee on Cancer classification system, eighth edition.
- •Underwent R0 gastrectomy with D2 lymphadenectomy.
- •No other concurrent malignancies.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •No contraindications to chemotherapy.
排除标准
- •Receipt of preoperative treatment, including radiation therapy, chemotherapy, or immunotherapy.
- •Patients with stage I, IIIC, or IV gastric cancer.
- •Severe cardiac, pulmonary, neurologic, hepatic, or other major organ dysfunction.
- •Known or suspected drug allergies.
- •Pregnant or lactating women.
研究组 & 干预措施
XELOX for 4 months
Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of 5 to 6 cycles, each lasting 3 weeks: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 5 to 6 months or until disease progression.
干预措施: Oxaliplatin (Drug)
XELOX for 4 months
Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of 5 to 6 cycles, each lasting 3 weeks: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 5 to 6 months or until disease progression.
干预措施: Capecitabine (Drug)
XELOX for 6 months
Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of eight 3-week cycles: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 6 months or until disease progression.
干预措施: Oxaliplatin (Drug)
XELOX for 6 months
Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of eight 3-week cycles: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 6 months or until disease progression.
干预措施: Capecitabine (Drug)
结局指标
主要结局
DFS
时间窗: 3-year
Disease-free survival
DFS
时间窗: 3 years
Disease-free survival, defined as the time from randomization to the first occurrence of disease recurrence or death from any cause.
次要结局
- OS(3-year)
- Adverse Events(6 months)
- OS(3 years)
- Adverse Events(6-month)