Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Improvement of dysphagia.
研究概览
简要总结
In this trial, patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent will be included. Primary objective is to determine the rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an improvement.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent
- •Any T, N and M
- •Age: 18 years or older
- •WHO performance status ≤ 2
- •Life expectancy > 3 months
- •Dysphagia score > 0
- •Adequate laboratory findings: hemoglobin > 90 g/L, absolute neutrophil count
- •1.0 10 9/L, platelets ≥ 75 x 10 9/L, bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 5 x ULN, creatinine ≤ 1.5 x ULN
- •Fertile men and women must use effective means of contraception
- •Signed written informed concent
- •The patient must be able to comply with the protocol
排除标准
- •Prior treatment with self-expanding metal stent (SEMS), radiotherapy or chemotherapy for the present disease
- •Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months) unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure
- •Severe pulmonary disease e.g. pulmonary fibrosis
- •Symptomatic peripheral neuropathy greater than grade 1 (CTCAE v. 4.0)
- •Known hypersensitivity to any contents of the study drugs
- •Pregnancy ( positive pregnancy test) and/or breast feeding
- •Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
研究组 & 干预措施
Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).
Radiotherapy (5 x 4 Gy) will be given. After completion of radiotherapy, 4 cycles of chemotherapy will be administered, cycle length 14 days. Each patient will receive oxaliplatin as infusion at a dose of 85 mg/m2, followed by a bolus injection of fluorouracil at a dose of 400 mg/m2, and a long time infusion (44 hours) of fluorouracil at a dose of 2 400 mg/m2.
干预措施: Radiation therapy (Radiation)
Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).
Radiotherapy (5 x 4 Gy) will be given. After completion of radiotherapy, 4 cycles of chemotherapy will be administered, cycle length 14 days. Each patient will receive oxaliplatin as infusion at a dose of 85 mg/m2, followed by a bolus injection of fluorouracil at a dose of 400 mg/m2, and a long time infusion (44 hours) of fluorouracil at a dose of 2 400 mg/m2.
干预措施: Oxaliplatin and fluorouracil. (Drug)
结局指标
主要结局
Improvement of dysphagia.
时间窗: The grade of dysphagia is evaluated before start of treatment, 1-4 weeks after end of radiotherapy, then until local intervention or death, average of 12 months.
The rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an approvement.
次要结局
- Endoscopic response of the primary tumor.(Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.)