Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- To compare the efficacy of full dose radiation therapy versus preoperative radiation therapy plus surgical resection, when used in combination with neo-adjuvant chemotherapy, in the treatment of localized esophageal cancer
研究概览
简要总结
In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU, and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy, along with one additional course of chemotherapy.
详细描述
Upon determination of eligibility, all patients will receive neo-adjuvant therapy with:
Paclitaxel + Carboplatin + 5-Fluorouracil + Radiation
After neo-adjuvant therapy and restaging are completed, patients will be randomized to receive one of two treatments:
- Surgical resection (Arm A)
- Paclitaxel + Carboplatin + Radiation (Arm B)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •To be included in this study, you must meet the following criteria:
- •Cancer of the esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
- •Received no previous treatment for esophageal cancer.
- •Measurable or evaluable disease
- •Able to perform activities of daily living with minimal assistance
- •Adequate bone marrow, liver and kidney function
- •Be at least 3 weeks from any major surgical procedures.
- •Have an indwelling central venous access catheter.
- •Patients must be able to understand the nature consent of the study and give written informed consent.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Age < 18 years
- •History of a prior malignancy within the past 5 years
- •History of significant heart disease
- •Inoperable on the basis of co-existent medical problems
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
To compare the efficacy of full dose radiation therapy versus preoperative radiation therapy plus surgical resection, when used in combination with neo-adjuvant chemotherapy, in the treatment of localized esophageal cancer
次要结局
- To compare the toxicity of these two treatment approaches in localized esophageal cancer
- To evaluate the utility of clinical restaging in guiding local therapy (surgical resection vs definitive radiation therapy) following neo-adjuvant treatment
- To evaluate the toxicity of additional chemotherapy and radiation therapy following completion of neo-adjuvant treatment.