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Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

NCT03254511 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-08-22

No results posted yet for this study

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.

Conditions

  • Esophageal Neoplasms

Interventions

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 \[area under the carve=2\]).

Sponsors & Collaborators

  • Mashhad University of Medical Sciences

    lead OTHER

Principal Investigators

  • Ali Taghizadeh Kermani, M.D. · Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

  • Sareh Hosseini, M.D. · Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

  • Seyed Alireza Javadinia, M.D. · Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

  • Arezoo Gholami, M.D. · Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-22
Primary Completion
2017-12-30
Completion
2018-12-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03254511 on ClinicalTrials.gov