Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

• Status: Unknown status
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mashhad University of Medical Sciences
• Treatments: Carboplatin; Enoxaparin; Enoxaparin sodium; Paclitaxel

Criteria

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