Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

Phase 2

• Conditions: Esophageal Neoplasms
• Interventions: Drug: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable; Radiation: Radiotherapy; Drug: Chemotherapeutic Combinations

• Registration Number: NCT03254511
• Lead Sponsor: Mashhad University of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2016-07-22
• Status Verified: 2017-08
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-18
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22
• Primary Completion: 2017-12-30
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enoxaparin	Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable	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).
control	Radiotherapy	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.
control	Chemotherapeutic Combinations	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.
enoxaparin	Radiotherapy	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).
enoxaparin	Chemotherapeutic Combinations	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).

Primary Outcome Measures

Name	Time	Method
R staging (residual of tumor)	up to 6 weeks	according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)
clinical response	up to 6 weeks	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)
pathologic response	up to 6 weeks	according to pathologic findings of esophageus specimen (complete Vs incomplete)

Secondary Outcome Measures

Name	Time	Method
heparin induced thrombocytopenia	through study completion, an average of 5 weeks	according to complete blood count

Trial Locations

Locations (1)

Mashhad University of Medical Sciences; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of