The Effect of Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer on the Clinical and Pathologic Response
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- R staging (residual of tumor)
研究概览
简要总结
This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. Sample size is 100 people (50 people in each group). In the intervention group, patients are going to inject an enoxaparin (40 mg) daily concurrent by chemo-radiation. Therefore patients with esophageal cancer are going to assign randomly to control group (only chemo-radiotherapy) and intervention group (chemo-radiotherapy+enoxaparin) using 1:1 allocation. Four to 6 weeks after treatment, all patients undergo upper GI endoscopy and then esophagectomy. Endoscopic and pathological findings (after esophagectomy) are considered as clinical and pathological response, respectively.
详细描述
This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. One hundred patients are going to assign randomly by blocked randomized allocation (1:1) to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with or without enoxaparin (40 mg daily). During radiotherapy and before each course of chemotherapy, all patients are going to visit by physician and complete blood count will be checked. All patients are going to undergo gastrointestinal endoscopy and then esophagectomy, 4-6 months after completion of chemo-radiotherapy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definitive diagnoses of esophageal squamous cell carcinoma by pathological evaluation
- •Non-metastatic esophageal cancer
- •Patient who are candidate for chemo-radiation treatment
- •Normal complete blood count
- •Normal kidney function test
- •Normal liver function test
- •Normal fasting blood sugar
排除标准
- •Previous history of chest wall radiotherapy
- •Previous history of chemotherapy
- •Past medical history of Hypertension, diabetes mellitus, renal failure and liver failure
- •Pathological report of adenocarcinoma or small cell carcinoma, neoplasm of other organs
- •Discontent for the study
- •Inability to do daily radiotherapy
- •Unwillingness to esophagectomy
研究组 & 干预措施
enoxaparin
In the enoxaparin group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable (40 mg daily).
干预措施: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable (Drug)
enoxaparin
In the enoxaparin group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable (40 mg daily).
干预措施: Radiotherapy (Radiation)
enoxaparin
In the enoxaparin group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable (40 mg daily).
干预措施: Chemotherapeutic Combinations (Drug)
control
In the control group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) alone.
干预措施: Radiotherapy (Radiation)
control
In the control group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) alone.
干预措施: Chemotherapeutic Combinations (Drug)
结局指标
主要结局
R staging (residual of tumor)
时间窗: up to 6 weeks
according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)
clinical response
时间窗: up to 6 weeks
according to endoscopic findings (no lesion, primary lesion or became smaller less than 50%of primary lesion, become smaller more than 50% of primary lesion)
pathologic response
时间窗: up to 6 weeks
according to pathologic findings of esophageus specimen (complete Vs incomplete)
次要结局
- heparin induced thrombocytopenia(through study completion, an average of 5 weeks)
研究者
Seyed Alireza Javadinia
Principal Investigator
Mashhad University of Medical Sciences