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临床试验/NCT02623153
NCT02623153Unknown2 期

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

Tianshu Liu0 个研究点目标入组 200 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

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:

  1. radical resection was unable after laparotomy or laparoscopic exploration.
  2. tumour invades adjacent structures such as the pancreas, liver, diaphragm, adrenal gland or transversa colon (T4b).
  3. 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

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

Active Comparator

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

Active Comparator

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

Experimental

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

Experimental

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

Experimental

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

发起方
Tianshu Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tianshu Liu

Chairman of the department of oncology

Shanghai Zhongshan Hospital

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