Phase 2 Study of Comparison Between XELOX (Capecitabine and Oxaliplatin) and Docetaxel, Oxaliplatin and S1 Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 主要终点
- response rate
研究概览
简要总结
The choice of neoadjuvant chemotherapy regimen for locally advanced gastric cancer is controversial. The aim of this study was to compare the short- and long-term outcomes of XELOX regimen with Docetaxel, S1 and oxaliplatin regimen as neoadjuvant chemotherapy regimen for locally advanced gastric cancer. The objective of this study is to determine what kind of neoadjuvant chemotherapy strategy can make subsequent radical surgery feasible and improve overall survival in patients with locally advanced gastric cancer.
详细描述
Patient selection
Patients with unresectable, histologically confirmed gastric adenocarcinoma with no distant metastases were eligible for the study. No-resectability was judged for technical reasons by a local multidisciplinary team, according to one of the following criteria:
- radical resection was unable after laparotomy or laparoscopic exploration.
- tumour invades adjacent structures such as the pancreas, liver, diaphragm, adrenal gland or transversa colon (T4b).
- Para-aortic (LN)lymph node metastasis ≥1.0 cm between the upper margin of the celiac artery and the upper border of the inferior mesenteric artery(stations no. 16a2/16b1), and/or bulky lymph nodes (≥3 cm×1 or≥1.5 cm×2) along the celiac, splenic, common or proper hepatic arteries, or the superior mesenteric vein;
All the patients received endoscopic examination, contrast CT scan for abdomen and pelvic, chest X-ray, as well as physical examination.
The exclusion criteria included: (1)peritoneal metastasis confirmed by CT scan; (2) lung metastasis, liver metastasis, pleural effusion, and/or other distant metastasis; (3) serious uncontrolled comorbid conditions; (4)any local intervention after initial diagnosis, such as surgical procedures, radiotherapy or trans-artery chemo-embolization;(5) patients who could not comprehend or comply with the study were also ineligible.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with unresectable, histologically confirmed gastric adenocarcinoma with no distant metastases were eligible for the study.
排除标准
- •peritoneal metastasis confirmed by CT scan
- •lung metastasis, liver metastasis, pleural effusion, and/or other distant metastasis
- •serious uncontrolled co-morbid conditions
- •lacking of measurable target lesion
- •any local intervention after initial diagnosis, such as surgical procedures, radiotherapy or trans-artery chemo-embolization
- •patients who could not comprehend or comply with the study were also ineligible.
研究组 & 干预措施
capecitabine and oxaliplatin
capecitabine of 1000 mg/m2, orally administered twice a day on days 1-14 and oxaliplatin at 130 mg/m2on day 1, as intravenous 2 h infusion
干预措施: Oxaliplatin (Drug)
capecitabine and oxaliplatin
capecitabine of 1000 mg/m2, orally administered twice a day on days 1-14 and oxaliplatin at 130 mg/m2on day 1, as intravenous 2 h infusion
干预措施: capecitabine (Drug)
S1, oxaliplatin and docetaxel
S1 of 40 mg/m2, orally administered twice a day on days 1-14,oxaliplatin 130 mg/m2 and docetaxel 40 mg/m2on day 1 as intravenous
干预措施: Oxaliplatin (Drug)
S1, oxaliplatin and docetaxel
S1 of 40 mg/m2, orally administered twice a day on days 1-14,oxaliplatin 130 mg/m2 and docetaxel 40 mg/m2on day 1 as intravenous
干预措施: S1 (Drug)
S1, oxaliplatin and docetaxel
S1 of 40 mg/m2, orally administered twice a day on days 1-14,oxaliplatin 130 mg/m2 and docetaxel 40 mg/m2on day 1 as intravenous
干预措施: Docetaxel (Drug)
结局指标
主要结局
response rate
时间窗: through study completion, an average of 24 weeks
次要结局
- R0 resection rate(through study completion, an average of 24 weeks)
- adverse events(through study completion, an average of 1 year)
- progression-free survival(through study completion, an average of 1 year)
- overall survival(through study completion, an average of 2 year)
研究者
Tianshu Liu
Chairman of the department of oncology
Shanghai Zhongshan Hospital
