A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 1
- 主要终点
- 3-yr overall survival
研究概览
简要总结
The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.
详细描述
Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a，TxNxM1a （according to AJCC2002）
Scheme:
Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio.
Arm Cisplatin:
Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Joined the study voluntarily and signed informed consent form;
- •Age 18-75
- •Both genders
- •Esophageal squamous cell carcinoma confirmed by pathology
- •Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)
- •No radiotherapy, chemotherapy or other treatments prior to enrollment
- •PS ECOG 0-2
- •Life expectancy of more than 3 months
- •Hemoglobin（Hb）≥9 g/dL
- •WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
- •platelet count (Pt) ≥100x 109/L
- •Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
- •Renal function: creatinine < 1.5 x ULN
- •No immuno-deficiency
- •Use of an effective contraceptive for adults to prevent pregnancy.
排除标准
- •Complete esophageal obstruction
- •Deep esophageal ulcer
- •Esophageal perforation
- •Haematemesis
- •After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
- •Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
- •Participation in other interventional clinical trials within 30 days
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- •Drug addiction
- •Alcoholism or AIDS
- •Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
- •Patient who has metastasis such as lung, liver metastasis
研究组 & 干预措施
Cisplatin
Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles.
干预措施: Cisplatin plus 5-fluorouracil (Drug)
Cisplatin
Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles.
干预措施: Radiation therapy (Radiation)
Paclitaxel
Patients randomized in Arm B will receive chemoradiation with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy with paclitaxel and 5-fluorouracil for 2 cycles.
干预措施: Paclitaxel plus 5-fluorouracil (Drug)
Paclitaxel
Patients randomized in Arm B will receive chemoradiation with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy with paclitaxel and 5-fluorouracil for 2 cycles.
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
3-yr overall survival
时间窗: 3 years
次要结局
- Disease progression-free survival(3 years)
- Local progression-free survival(3 years)
- Number and grade of Participants with Adverse Events(6 months)
研究者
Kuai Le Zhao, MD
Principal Investigator
Fudan University