NCT02213497进行中（未招募）1 期
Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.
详细描述
- To identify the maximally tolerated radiation dose (MTD) of dose-escalated proton radiotherapy in combination with carboplatin/paclitaxel in the preoperative setting for esophageal cancer.
- To estimate pathologic response rates by esophagectomy surgical specimens after escalated doses of chemoradiotherapy.
- To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to predict treatment response to chemoradiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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 a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
- •Patients with AJCC 7th edition clinical stage IIB-IIIC
- •Patient must be >18 years of age.
- •Patients must have an ECOG Performance Status of 0-1
- •Patients must be able to provide informed consent.
- •Patients must be surgical candidates with adequate hematologic, renal, hepatic and pulmonary function
- •serum AST and ALT < 2 times the upper limit of normal
- •Patients must have bilirubin < 1.5 × normal.
- •WBC > 3000/mm3, platelets > 100,000 mm
- •Hemoglobin > 10 g/dL serum creatinine < 1.5 times the upper limit of normal
- •Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.
排除标准
- •Patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should be measured by endoscopic findings, width should be measured by diagnostic CT or CT portion of PET/CT)
- •Patients with primary tumors located at or above the carina
- •Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
- •Pregnant women, women planning to become pregnant and women that are nursing
研究组 & 干预措施
Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
Experimental
Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
干预措施: 18F-FDG (Fluorodeoxyglucose) PET (Radiation)
Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
Experimental
Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
干预措施: Carboplatin (Drug)
Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
Experimental
Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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