Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Esophageal Neoplasms

Clinical Trial Details

NCT number	NCT03254511
Study type	Interventional
Source	Mashhad University of Medical Sciences
Contact	Arezoo Gholami, M.D.
Phone	00989155252690
Email	gholamia931@mums.ac.ir
Status	Recruiting
Phase	Phase 2
Start date	July 22, 2016
Completion date	December 30, 2018

View Details

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