Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

NCT03254511 | Unknown Phase 2 DMC

• 2 other identifiers: 941703IRCT2016070628814N1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms

Keywords

neoadjuvant chemoradiation; pathologic response; low molecular weight heparin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• heparin induced thrombocytopenia

  through study completion, an average of 5 weeks

Study Arms (2)

enoxaparin

EXPERIMENTAL

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; Radiation: Radiotherapy; Drug: Chemotherapeutic Combinations

control

ACTIVE COMPARATOR

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; Drug: Chemotherapeutic Combinations

Interventions

Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable DRUG

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

enoxaparin

Radiotherapy RADIATION

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

control; enoxaparin

Chemotherapeutic Combinations DRUG

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

control; enoxaparin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad University of Medical Sciences

Mashhad, Khorasan Razavi, 917751365, Iran

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

enoxaparin sodium; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ali Taghizadeh Kermani, M.D.

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

  STUDY CHAIR

• Sareh Hosseini, M.D.

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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arezoo Gholami, M.D.

CONTACT

00989155252690; gholamia931@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 18, 2017
• Study Start: July 22, 2016
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2018
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

IR (1)