A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- RECIST(Response Evaluation Criteria in Solid Tumors)
研究概览
简要总结
Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.
详细描述
Treatment scheme
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Screening period: D-21 to D1 (treatment day)
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Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan.
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Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998)
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Tumor response is assessed every 2 cycles (6 weeks)
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Treatment is repeated until,.
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4 cycles
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progressive disease
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unacceptable toxicity
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patient's withdrawal
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Gastric surgery should be performed within 4~6 weeks of the last dose of chemotherapy
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Gastric surgery is for curative aim and should include ≥ D2 LN dissection.
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Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin.
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Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy.
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Follow up for survival is repeated every 3 months for 2 years
Study period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months
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
- •Histologically/cytologically confirmed gastric adenocarcinoma
- •Age 18 to 70 years old
- •ECOG performance Status 0~1
- •Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA~IV), M0, P0, H0, CY0
- •No pretreatment (radiotherapy or chemotherapy) for gastric cancer
- •Adequate organ function
- •Hb ≥ 9.0 g/dL
- •WBC ≥ 4,000/µL
- •ANC ≥ 2,000/µL (*ANC = Neutrophil segs ＋ Neutrophil bands)
- •Platelet ≥ 100 × 103/ µL
- •Total bilirubin: ≤ 1.5 × UNL
- •CCr ≥ 60 ml/min (by laboratory or Cockcroft-Gault Formula)
- •AST/ALT, ALP: ≤ 2.5 × UNL
- •Written informed consent
排除标准
- •Distant metastasis on diagnosis
- •Cancer of gastroesophageal junction (GEJ)
- •Poor oral intake or absorption deficiency syndrome
- •Gastric outlet obstruction, perforation or bleeding
- •Medically uncontrollable chronic illness or infection
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •History of clinically significant cardiac disease
- •Past or concurrent history of neoplasm last < 5 year other than gastric cancer
- •Prior gastrectomized patients
- •Concomitant administration of any other experimental drug under investigation
- •Peripheral neuropathy ≥ NCI-CTC grade 2
研究组 & 干预措施
DCS
DCS: docetaxel with cisplatin with TS-1
干预措施: DCS (docetaxel with cisplatin with TS-1) (Drug)
DCF
DCF : docetaxel with cisplatin with 5-FU
干预措施: DCF (docetaxel with cisplatin with 5-FU) (Drug)
结局指标
主要结局
RECIST(Response Evaluation Criteria in Solid Tumors)
时间窗: written in the description part below
* safety : every cycle adverse event/serious adversr event evaluation from NCI-CTC(version 3.0) * efficacy : tumor response is assessed every 2 cycles (6weeks) -\> tumor response assessment(RECIST\<Response Evaluation Criteria in Solid Tumor\> 1.0 version use)
次要结局
未报告次要终点