drugset / Trial / NCT03254511

Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

NCT03254511

Phase 2 Unknown 100 enrolled Mashhad University of Medical Sciences
RandomizedParallel-groupSingle-blindTreatment

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

EvaluationDrugModalityDoseRoute
Subject Enoxaparin sodium Other / unclassified 40 mg Subcutaneous
Background Carboplatin Small molecule
Background Paclitaxel Small molecule 50 mg/m2

Indications