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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Khorasan Razavi
    • Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 917751365
      • Recruiting
      • Mashhad University of Medical Sciences
      • Contact: Mohsen Tafaghodi, M.D.; Phone Number: 00985138823255; Email: vcresearch@mums.ac.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: enoxaparin; 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; 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]).
ACTIVE_COMPARATOR: control; 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; 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]).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences
• Investigators: Study Chair: Ali Taghizadeh Kermani, M.D., Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran; Study Director: Sareh Hosseini, M.D., Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran; Principal Investigator: Seyed Alireza Javadinia, M.D., Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran; Principal Investigator: Arezoo Gholami, M.D., Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2016
• Primary Completion (ANTICIPATED): December 30, 2017
• Study Completion (ANTICIPATED): December 30, 2018

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (ACTUAL): August 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: neoadjuvant chemoradiation; low molecular weight heparin; pathologic response
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: 941703; IRCT2016070628814N1 (REGISTRY: the Iranian Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No