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Trial record 5 of 384 for:    Recruiting, Not yet recruiting, Available Studies | "Esophageal Neoplasms"

Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03254511
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Seyed Alireza Javadinia, Mashhad University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Drug: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable Radiation: Radiotherapy Drug: Chemotherapeutic Combinations Phase 2

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer on the Clinical and Pathologic Response
Actual Study Start Date : July 22, 2016
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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]).




Primary Outcome Measures :
  1. clinical response [ Time Frame: up to 6 weeks ]
    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)

  2. pathologic response [ Time Frame: up to 6 weeks ]
    according to pathologic findings of esophageus specimen (complete Vs incomplete)

  3. R staging (residual of tumor) [ Time Frame: up to 6 weeks ]
    according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)


Secondary Outcome Measures :
  1. heparin induced thrombocytopenia [ Time Frame: through study completion, an average of 5 weeks ]
    according to complete blood count



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254511


Contacts
Contact: Arezoo Gholami, M.D. 00989155252690 gholamia931@mums.ac.ir

Locations
Iran, Islamic Republic of
Mashhad University of Medical Sciences Recruiting
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 917751365
Contact: Mohsen Tafaghodi, M.D.    00985138823255    vcresearch@mums.ac.ir   
Sponsors and Collaborators
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

Responsible Party: Seyed Alireza Javadinia, Principal Investigator, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03254511     History of Changes
Other Study ID Numbers: 941703
IRCT2016070628814N1 ( Registry Identifier: the Iranian Registry of Clinical Trials )
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seyed Alireza Javadinia, Mashhad University of Medical Sciences:
neoadjuvant chemoradiation
pathologic response
low molecular weight heparin

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Carboplatin
Enoxaparin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents