NCT03254511

Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

The Effect of Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer on the Clinical and Pathologic Response

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mashhad University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Esophageal Neoplasms

Interventions

Type	Name	Description
DRUG	Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable	Patients are going to receive subcutaneouse Enoxaparin (40 mg daily).
RADIATION	Radiotherapy	Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.
DRUG	Chemotherapeutic Combinations	Patients are going to receive weekly chemotherapy (paclitaxel \[50 mg/m2\] plus carboplatin \[area under the carve=2\]).

Timeline

• Start date: 2016-07-22
• Primary completion: 2017-12-30
• Completion: 2018-12-30
• First posted: 2017-08-18
• Last updated: 2017-08-22

Locations

1 site across 1 country: Iran