Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Drug: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable
* Radiation: Radiotherapy
* Drug: Chemotherapeutic Combinations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enoxaparin<br>In the enoxaparin group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable (40 mg daily). | Drug: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable<br>* Patients are going to receive subcutaneouse Enoxaparin (40 mg daily).<br>Radiation: Radiotherapy<br>* Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.<br>Drug: Chemotherapeutic Combinations<br>* Patients are going to receive weekly chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]).<br>|
| Active Comparator: control<br>In the control group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) alone. | Radiation: Radiotherapy<br>* Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.<br>Drug: Chemotherapeutic Combinations<br>* Patients are going to receive weekly chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response | according to endoscopic findings (no lesion, primary lesion or became smaller less than 50%of primary lesion, become smaller more than 50% of primary lesion) | up to 6 weeks | 
| pathologic response | according to pathologic findings of esophageus specimen (complete Vs incomplete) | up to 6 weeks | 
| R staging (residual of tumor) | according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue) | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heparin induced thrombocytopenia | according to complete blood count | through study completion, an average of 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoadjuvant chemoradiation, pathologic response, low molecular weight heparin