Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

Mashhad University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Esophageal Neoplasms

Treatments: Radiation: Radiotherapy; Drug: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable; Drug: Chemotherapeutic Combinations

Study type: Interventional

Funder types: Other

Identifiers

NCT03254511

IRCT2016070628814N1 (Registry Identifier)

941703

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

enoxaparin

Experimental group

Description:

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).

Treatment:

Radiation: Radiotherapy

Drug: Chemotherapeutic Combinations

Drug: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable

control

Active Comparator group

Description:

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.

Treatment:

Radiation: Radiotherapy

Drug: Chemotherapeutic Combinations