Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Disease free survival
研究概览
简要总结
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma
详细描述
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma.
Patients with resectable esophageal squamous cell carcinoma receive 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). Patients who do not progress with distant metastases start preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gy for 4 weeks).
4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy irrespectively of objective response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed resectable squamous-cell Tumor (T)1-2 node (N)+, T3N0-3 esophageal cancer. Inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed
- •No prior antineoplastic treatment
- •Eastern Cooperative Oncology Group (ECOG) status 0-2
- •Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy
- •absolute neutrophil count ≥ 1,500 х109/l
- •thrombocytes ≥ 100 х 109/l
- •hemoglobin ≥ 90 mg/l
- •creatinine < 115 µmol/л or creatinine clearance ≥ 55 ml/min
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)
- •alkaline phosphatase (ALP) > 5 x ULN
- •bilirubin > 1,5 х ULN
- •Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment
- •Patients must follow appropriate contraception rules during whole treatment period
- •Decrease of body weight must not be more than 20% in last 6 months
排除标准
- •Presence of distant metastases except for metastatic supraclavicular lymphnodes;
- •Bulky (>3 cm) regional lymphnodes metastases;
- •Cervical esophageal cancer;
- •Presence of tumor fistula;
- •Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer;
- •Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;
研究组 & 干预措施
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks).
4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
干预措施: Paclitaxel (Drug)
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks).
4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
干预措施: Cisplatin (Drug)
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks).
4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
干预措施: Fluorouracil (Drug)
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks).
4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
干预措施: chemoradiotherapy (Radiation)
Trimodality approach
2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks).
4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.
干预措施: Ivor Lewis esophagogastrectomy (Procedure)
结局指标
主要结局
Disease free survival
时间窗: 24 months
Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.
次要结局
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0(24 months)
- Objective response rate according to RECIST 1.1(24 months)
- Overall survival(24 months)
- Pathological complete response rate following chemoradiotherapy(24 months)
研究者
Mona Frolova
Senior Staff Member
Russian Academy of Medical Sciences