Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer
Summary
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.
Timeline
- Start
- 2016-07-22
- Primary completion
- 2017-12-30
- Completion
- 2018-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enoxaparin sodium | Other / unclassified | 40 mg | Subcutaneous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | 50 mg/m2 | — |