A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.
试验速览
- 阶段
- 3 期
- 入组人数
- 588
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric cancer;
- •D2 and R0 resection;
- •Pathologically confirmed stage anyT, N+, M0 (AJCC Cancer Staging);
- •Karnofsky performance score (KPS) >= 70 or Eastern Cooperative Oncology Group(ECOG) score 0-1;
- •Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL）
- •No allergic history of 5-Fu or Platinum drugs;
- •No history of chemotherapy or other anti-cancer therapy;
- •Informed consent should be signed.
排除标准
- •GEJ adenocarcinoma
- •Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)
- •Allergic to Fluorouracil or Platinum drugs;
- •Concurrent uncontrolled medical condition;
- •Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;
- •Severe postoperative complications such as anastomotic leakage, etc.;
- •Symptoms or history of peripheral neuropathy.
研究组 & 干预措施
Adjuvant Chemotherapy
The interventions of adjuvant chemotherapy group is 8 cycles of SOX(S-1+Oxaliplatin) chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
干预措施: Adjuvant chemotherapy for active comparator group (Drug)
Adjuvant Chemo-radiotherapy
The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
干预措施: Adjuvant Concurrent Chemo-radiotherapy (Radiation)
Adjuvant Chemo-radiotherapy
The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
干预措施: Adjuvant chemotherapy for experimental group (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 3 years
次要结局
- Over all survival(3 years)
- Local recurrence free survival(3 years)
- Distant metastasis free survival(3 years)
- Adverse Event(3 years)
研究者
Jing Jin, M.D.
M.D.
Chinese Academy of Medical Sciences