Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03254511
• Other study ID #: 941703
• Secondary ID: IRCT201607062881
• Status: Recruiting
• Phase: Phase 2
• First received: August 11, 2017
• Last updated: August 21, 2017
• Start date: July 22, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: August 2017
• Source: Mashhad University of Medical Sciences
• Contact: Arezoo Gholami, M.D.
• Phone: 00989155252690
• Email: gholamia931[@]mums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

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]).

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad University of Medical Sciences	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	pathologic response	according to pathologic findings of esophageus specimen (complete Vs incomplete)	up to 6 weeks
Primary	R staging (residual of tumor)	according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)	up to 6 weeks
Secondary	heparin induced thrombocytopenia	according to complete blood count	through study completion, an average of 5 weeks