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Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

Primary Purpose

Esophageal Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable

Radiotherapy

Chemotherapeutic Combinations

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring neoadjuvant chemoradiation, pathologic response, low molecular weight heparin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mashhad University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

enoxaparin

control

Arm 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).

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.

Outcomes

Primary Outcome Measures

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)

pathologic response

according to pathologic findings of esophageus specimen (complete Vs incomplete)

R staging (residual of tumor)

according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)

Secondary Outcome Measures

heparin induced thrombocytopenia

according to complete blood count

Full Information

NCT ID

NCT03254511

First Posted

August 11, 2017

Last Updated

August 21, 2017

Sponsor

Mashhad University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03254511

Brief Title

Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 22, 2016 (Actual)

Primary Completion Date

December 30, 2017 (Anticipated)

Study Completion Date

December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mashhad University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Neoplasms

Keywords

neoadjuvant chemoradiation, pathologic response, low molecular weight heparin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

enoxaparin

Arm Type

Experimental

Arm Description

Arm Title

control

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Chemotherapeutic Combinations

Intervention Description

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

Primary Outcome Measure Information:

Title

clinical response

Description

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)

Time Frame

up to 6 weeks

Title

pathologic response

Description

according to pathologic findings of esophageus specimen (complete Vs incomplete)

Time Frame

up to 6 weeks

Title

R staging (residual of tumor)

Description

according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)

Time Frame

up to 6 weeks

Secondary Outcome Measure Information:

Title

heparin induced thrombocytopenia

Description

according to complete blood count

Time Frame

through study completion, an average of 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arezoo Gholami, M.D.

Phone

00989155252690

gholamia931@mums.ac.ir

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ali Taghizadeh Kermani, M.D.

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sareh Hosseini, M.D.

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Seyed Alireza Javadinia, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arezoo Gholami, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mashhad University of Medical Sciences

City

Mashhad

State/Province

Khorasan Razavi

ZIP/Postal Code

917751365

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohsen Tafaghodi, M.D.

Phone

00985138823255

vcresearch@mums.ac.ir

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

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