Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer
关键词
抽象
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.
日期
| 最后验证: | 07/31/2017 |
| 首次提交: | 08/10/2017 |
| 提交的预估入学人数: | 08/14/2017 |
| 首次发布: | 08/17/2017 |
| 上次提交的更新: | 08/20/2017 |
| 最近更新发布: | 08/21/2017 |
| 实际学习开始日期: | 07/21/2016 |
| 预计主要完成日期: | 12/29/2017 |
| 预计完成日期: | 12/29/2018 |
状况或疾病
干预/治疗
Drug: enoxaparin
Radiation: Radiotherapy
Drug: Chemotherapeutic Combinations
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 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). | Drug: enoxaparin Patients are going to receive subcutaneouse Enoxaparin (40 mg daily). |
| Active Comparator: 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. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. clinical response [up to 6 weeks]
2. pathologic response [up to 6 weeks]
3. R staging (residual of tumor) [up to 6 weeks]
次要成果指标
1. heparin induced thrombocytopenia [through study completion, an average of 5 weeks]
