Phase I Trial of Radiation Dose Escalation With Concurrent Weekly Cisplatin and Paclitaxel in Patients With Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Dose Limiting Toxicities (DLTs) Occurring in Participants
研究概览
简要总结
The aim of this trial is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (DDP & Paclitaxel) in patients with inoperable or medically unresectable esophageal cancer.
详细描述
The RTOG 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional remain problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the combined modality approach. New regimen is urgently needed for improving localregional control and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label
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.
- •Patients with distant metastasis and life expectancy >/= 3 months are eligible.
- •Zubrod 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. 1
- •Induction chemotherapy is allowed.
排除标准
- •The presence of a fistula.
- •Prior radiotherapy that would overlap the radiation fields.
- •gastroesophageal junction cancer.
- •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
Number of Dose Limiting Toxicities (DLTs) Occurring in Participants
时间窗: 15 months
The DLTs were defined as grade \>/=4 esophatitis, any other grade \>/=3 nonhematological toxicity (except nausea and vomiting), or grade \>/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment.
次要结局
- Local Failure(15 months)
研究者
Chen tingfeng
Director,department of radiation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine