Phase II Study of High-dose （86 Gy）Intensity Modulated Radiotherapy and Concurrent Paclitaxel and Cisplatin in Locoregionally Advanced Esophageal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- overall survival rate
研究概览
简要总结
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced esophageal cancer
详细描述
The Radiation Therapy Oncology Group (RTOG) 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional failure remains problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the standard dose (50-50.4 Gy) chemoradiotherapy . Our previous phase I radiation dose escalation trial established the maximum tolerated dose of 86 Gy with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.
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 confirmed primary squamous cell carcinoma of the esophagus
- •Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons.
- •Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2
- •No prior radiation to the thorax that would overlap with the current treatment field.
- •Patients with nodal involvement are eligible
- •Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </ =1 .5 times ULN.
- •A signed informed consent must be obtained prior to therapy.
- •Induction chemotherapy is allowed
排除标准
- •The presence of a fistula.
- •Prior radiotherapy that would overlap the radiation fields.
- •gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall.
- •Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
- •Known hypersensitivity to paclitaxel.
- •Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
- •Acquired Immune Deficiency Syndrome.
- •Conditions precluding medical follow-up and protocol compliance
结局指标
主要结局
overall survival rate
时间窗: one year
survival time was measured from the date of study enrollment to the date of death or last follow-up
次要结局
- toxicities(1 year)
研究者
Chen tingfeng
director, department of radiation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine