Concurrent Radiotherapy and Weekly Chemotherapy of 5-fluorouracil and Cisplatin for Postoperative Locoregional Recurrence of Oesophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative locoregional recurrence of esophageal squamous cell carcinoma.
详细描述
The most optimal management for postoperative locoregional recurrence of oesophageal squamous cell carcinoma is still controversial. Several studies have reported the feasibility and efficacy of concurrent chemoradiotherapy (CCRT), mostly with three-weekly or four-weekly schedule of chemotherapy. However, treatment compliance was not quite satisfactory, probably due to treatment-related toxicities. Since CCRT with weekly chemotherapy regimens have demonstrated a favorable toxicity profile as well as promising survival in certain types of cancer, the investigators aimed to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy with 5-fluorouracil (5-FU) and cisplatin for patients with postoperative locoregional recurrence of oesophageal squamous cell carcinoma in the investigators center.The prescribed dose of radiotherapy is generally 60Gy/28fr to tumor and 50Gy/28fr to the clinical target volume.The concomitant chemotherapy is cisplatin 25mg/m2 on day 1, 5-FU 1176mg/m2 on day 1-3, repeated weekly for 4 weeks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •R0 resection for primary esophageal squamous cell carcinoma with two-incision esophagectomy (Ivor Lewis approach)25 or three-incision (right thoracotomy, midline laparotomy and left cervical incisions) esophagectomy with cervical esophagogastric anastomosis.
- •Absence of previous thoracic radiotherapy.
- •Cervical and/or thoracic postoperative recurrence (biopsy proven or positron emission tomography/computed tomography (PET/CT) proven or follow-up computed tomography (CT) showed progression of disease).
- •Absence of distant metastasis at recurrence.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
排除标准
- •Younger than 18 or older than 70 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above
- •Other cancer history.
- •Serious cardiac, liver, or pulmonary disease.
- •Previous radiotherapy history
研究组 & 干预措施
Weekly PF with radiation
4 cycles of weekly cisplatin and fluorouracil (cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3, repeated weekly for 4 weeks) concurrently with Intensity-modulated radiation therapy (60Gy/28fr).
干预措施: fluorouracil (Drug)
Weekly PF with radiation
4 cycles of weekly cisplatin and fluorouracil (cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3, repeated weekly for 4 weeks) concurrently with Intensity-modulated radiation therapy (60Gy/28fr).
干预措施: Cisplatin (Drug)
Weekly PF with radiation
4 cycles of weekly cisplatin and fluorouracil (cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3, repeated weekly for 4 weeks) concurrently with Intensity-modulated radiation therapy (60Gy/28fr).
干预措施: Intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
overall response rate
时间窗: within 8 weeks after the treatment(plus or minus 5 days)
RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine the tumor response. Tumor response was evaluated by CT 8 weeks after chemoradiotherapy.
次要结局
- safety: Toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0).(up to 3 years)
- overall survival(up to 3 years)
研究者
Zhu Yujia
Attending physicion
Sun Yat-sen University