Phase IIB Study of Trimodality Management of Clinical T1bN0M0 Cancers of the Esophagus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response (PCR) Rate
研究概览
简要总结
The goal of this clinical research study is to learn if giving chemotherapy and radiation therapy before surgery for early-stage esophageal cancer can help to control the disease and if so, for how long. The safety of this treatment will also be studied.
详细描述
The Study Treatment:
5-fluorouracil and docetaxel are designed to stop the growth of cancer cells, which may cause the cells to die. Docetaxel may also damage blood vessels in tumor tissue.
The radiation therapy in this study will be either intensity modulated radiation therapy (IMRT), which is a form of photon-based radiation therapy, or proton beam therapy (PBT). This will be up to your doctor. Both IMRT and PBT are designed to give radiation to the tumor area and limiting radiation exposure to nearby organs such as the lungs, heart, and spinal cord.
The surgery in this study removes part of the esophagus and nearby lymph nodes. The type of surgery will be the doctor's decision based on the location of the tumor in the esophagus. It will either be laparoscopic surgery (a minimally invasive procedure through small holes made in the abdomen) or open surgery (through the chest wall).
Study Treatment Administration:
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
- •Histologically documented adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction that are staged as T1b using endoscopic ultrasound (EUS) or from a large biopsy (either criteria # 1 or #2 can be met for eligibility).
- •Patients who undergo a diagnostic Endoscopic Mucosal Resection (EMR) and have a diagnosis of T1b stage established.
- •Performance score Karnofsky Performance Scale (KPS) 80-
- •Patients should be surgical candidates for esophagectomy and should have no contraindications for chemotherapy or radiation.
- •Negative pregnancy test for women of child bearing potential. They must agree to adequate contraception.
- •Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, CO2, Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, ALT (SGPT), AST (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) >2,500/uL, platelets > 75,000/uL), renal (creatinine clearance > 50 mL/min), and liver function (bilirubin <=1.5 fold the upper limit of normal and liver enzymes < 3 fold the upper limit of normal).
- •Based on the risk factors and propensity of lymph node metastasis (LNM) and poorer survivals seen in retrospective studies as discussed in the introduction, only patients with any one (1) of high risk features such as LVI, tumors >1.2 cm, and high grade will be enrolled (Grade is the pathologic term defining the degree of differentiation. Grade 1 is well differentiated, Grade 2 is moderately differentiated, and Grade 3 is poorly differentiated).
排除标准
- •Prior radiation to the chest
- •Previous or concomitant cancers other than 1) curatively treated carcinoma in situ of cervix, basal cell of the skin, curative treatment for transitional cell carcinoma of the bladder, and early stage cancers at another non-overlapping site that was treated more than 3 years ago for cure.
- •Pregnant or breast-feeding females
- •Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device c) no myocardial infarction within 3 months of registration
- •Known hypersensitivity to docetaxel, 5-fluorouracil, polysorbate-80, or any component of the formulation
研究组 & 干预措施
Docetaxel + 5-FU + Radiation + Surgery
Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
干预措施: Docetaxel (Drug)
Docetaxel + 5-FU + Radiation + Surgery
Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
干预措施: 5-FU (Drug)
Docetaxel + 5-FU + Radiation + Surgery
Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
干预措施: Radiotherapy (Radiation)
Docetaxel + 5-FU + Radiation + Surgery
Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
干预措施: Esophagectomy (Procedure)
Docetaxel + 5-FU + Radiation + Surgery
Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Pathologic Complete Response (PCR) Rate
时间窗: Pathologic Complete Response (PCR) will repeat EGD with biopsy to assess for clinical response to therapy after chemoradiation four to six weeks.
The primary endpoint for this protocol is to assess the efficacy (pathologic complete response) and safety of Trimodality management (chemoradiotherapy followed by esophagectomy) in patients with clinically staged T1bN0M0 cancer of the esophagus or gastroesophageal junction. This is a single-arm phase IIB trial of chemo-radiation followed by surgery for patients with early stage grade T1b esophageal cancer. The rates of pathologic CR will be tabulated and their possible relationships to baseline covariates assessed by logistic regression. Unadjusted progression free survival time will be estimated by the method of Kaplan and Meier and its possible relationship to baseline covariates assessed by survival regression modeling.
次要结局
- Disease-free Survival (DFS) Time(Time to disease progression or death, up to 6 years)