Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

NCT ID: NCT03254511

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-22
• Study Completion Date: 2018-12-30

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.

Conditions

Esophageal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable

Intervention Type: DRUG

Patients are going to receive subcutaneouse Enoxaparin (40 mg daily).

Radiotherapy

Intervention Type: RADIATION

Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.

Chemotherapeutic Combinations

Intervention Type: DRUG

Patients are going to receive weekly chemotherapy (paclitaxel \[50 mg/m2\] plus carboplatin \[area under the carve=2\]).

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.

Group Type: ACTIVE_COMPARATOR

Radiotherapy

Intervention Type: RADIATION

Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.

Chemotherapeutic Combinations

Intervention Type: DRUG

Patients are going to receive weekly chemotherapy (paclitaxel \[50 mg/m2\] plus carboplatin \[area under the carve=2\]).

Interventions

Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable

Patients are going to receive subcutaneouse Enoxaparin (40 mg daily).

Intervention Type: DRUG

Radiotherapy

Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.

Intervention Type: RADIATION

Chemotherapeutic Combinations

Patients are going to receive weekly chemotherapy (paclitaxel \[50 mg/m2\] plus carboplatin \[area under the carve=2\]).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Seyed Alireza Javadinia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Taghizadeh Kermani, M.D.

Role: STUDY_CHAIR

Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

Sareh Hosseini, M.D.

Role: STUDY_DIRECTOR

Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

Seyed Alireza Javadinia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

Arezoo Gholami, M.D.

Role: PRINCIPAL_INVESTIGATOR

Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

Locations

Mashhad University of Medical Sciences

Mashhad, Khorasan Razavi, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Arezoo Gholami, M.D.

Role: CONTACT

gholamia931@mums.ac.ir

00989155252690

Facility Contacts

Mohsen Tafaghodi, M.D.

Role: primary

vcresearch@mums.ac.ir

00985138823255

Other Identifiers

IRCT2016070628814N1

Identifier Type: REGISTRY

Identifier Source: secondary_id

941703

Identifier Type: -

Identifier Source: org_study_id