Compare Neoadjuvant Chemotherapy of DOS Versus SOX in Locally Advanced Gastric Adenocarcinoma.

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合作者:

信息的提供 (责任方):

Shen Lin，Peking University

追踪信息

首次提交日期 ^ICMJE

September 11, 2018

首次发布日期e ^ICMJE

October 1, 2018

最后更新发布日期

October 1, 2018

预计研究开始日期 ^ICMJE

June 28, 2018

预计主要完成日期

June 30, 2022 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

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

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Overall Survival : From date of enrollment until the date of death[ Time Frame: 5 years ]
Evaluation of the Overall Survival of DOS regimen versus SOX regimen in locally advanced gastric adenocarcinoma
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.[ Time Frame: 3 years ]
Evaluation of the Progression-free Survival of DOS regimen versus SOX regimen in locally advanced gastric adenocarcinoma

描述性信息

简略标题 ^ICMJE

Compare Neoadjuvant Chemotherapy of DOS Versus SOX in Locally Advanced Gastric Adenocarcinoma.

正式标题 ^ICMJE

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)

简要概况

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

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2/Phase 3

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Docetaxel
Docetaxel 50mg/m2, intravenous drip, D1, combined with Oxaliplatin 85mg/m2，intravenous drip 2h，D1 and S-1 40-60mg bid(BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid)，D1-7；For patients with Her2 positive, add Herceptin 4mg/kg(6mg/kg first cycle) D1; every 14 days for a cycle.
Drug: Oxaliplatin
Oxaliplatin 130mg/m2，intravenous drip 2h，D1 combined with S-1 40-60mg bid(BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid)，D1-14；For patients with Her2 positive, add Herceptin 6mg/kg(8mg/kg first cycle) D1; every 21 days for a cycle.

研究工具

Experimental: DOS
Docetaxel+Oxaliplatin+S-1
Active Comparator: SOX
Oxaliplatin+S-1

招募信息

招募状态 ^ICMJE

Active, not recruiting

预计入组 ^ICMJE

258

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

June 30, 2023

预计主要完成日期

June 30, 2022 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Ambulatory males or females with ages ≥ 18. 2. Karnofsky performance status ≥ 70%. 3. Histologically confirmed gastric adenocarcinoma including Lauren classification and validated overexpression of HER2. 4. cTNM should be diagnosed by enhanced CT/MRI (combined with endoscopic ultrasonography and diagnostic laparoscopic exploration) as cIII/IVa according to AJCC 8th classification. 5. Radical resection is possible before operation. 6. 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). 7. Physiological status and organ function are acceptable for major abdominal surgical operation. 8. 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. 9. Left ventricular ejection fraction evaluated by echocardiac scanning ≥ 50%. 10. No severe comorbidity with less than 5 year survival. 11. Willing to receive the regimens in this study. 12. Sign written informed consent form before screening of study, and can withdraw in any time with no loss. 13. Agree to provide blood sample and histological specimen. Exclusion Criteria： 1. Pregnancy or lactation women. 2. Woman of childbearing age was not tested in baseline pregnancy test or tested positve. Postmenopausal women with amenorrhea for at least 12 months are considered nonpregnancy. 3. Sexually active males or females refuse to practice contraception during the study. 4. With distant metastasis diagnosed by CT/EUS. 5. Underwent prior antitumor treatment including chemotherapy, radiotherapy or immunotherapy except steroid therapy. 6. Suffered from other malignant tumors in previous 5 years, with the exception of cured cutaneum carcinoma and cervical carcinoma in situ. 7. Patients with uncontrolled seizure, central nervous system disorder or psychiatric disease will be judged by researchers whether severity influences signing informed consent or compliance to take medicine. 8. Suffered from severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure ≥ II grade according to NYHA (New York Heart Association) standard, uncontrolled cardiac arrhythmia, cardiac infarction within 12 months prior to study enrollment. 9. Complicated by upper gastrointestinal obstruction or abnormal digestive function or malabsorption syndrome, which may affect the absorption of S-1. 10. Known peripheral nervous system disorder ≥ NCI CTC AE 1 grade with the exception of only disappearance of deep tendon reflex (DRT). 11. History of organ transplantation with immunosuppression therapy. 12. Complicated with severe uncontrolled concurrent infection or other severe uncontrolled concominant diseases, moderate or severe kidney injury (creatinine clearance rate ≤ 50 ml/min according to Cockcroft and Gault formula), or serum creatinine serum > the upper limit of normal (ULN) 13. Lack of dihydropyrimidine dehydrogenase (DPD). 14. Allergic reaction to platinum compounds or other agents used in this study. 15. Patients who have received study agents within 4 weeks (participating in other clinical trials).

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

China

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Shen Lin，Peking University

研究赞助商 ^ICMJE

Peking University

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Jiafu Ji, Professor Beijing Cancer Hospital

PRS 账户

Peking University

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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