Clinical trial NCT03254511: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Neoplasms
Keywords: neoadjuvant chemoradiation
pathologic response
low molecular weight heparin
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: clinical response
timeFrame: up to 6 weeks
measure: pathologic response
timeFrame: up to 6 weeks
measure: R staging (residual of tumor)
timeFrame: up to 6 weeks
Secondary outcomes:
measure: heparin induced thrombocytopenia
timeFrame: through study completion, an average of 5 weeks
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Sciences
state: Khorasan Razavi
Study officials:
affiliation: Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
name: Ali Taghizadeh Kermani, M.D.
role: STUDY_CHAIR
affiliation: Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
name: Sareh Hosseini, M.D.
role: STUDY_DIRECTOR
affiliation: Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
name: Seyed Alireza Javadinia, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
name: Arezoo Gholami, M.D.
role: PRINCIPAL_INVESTIGATOR
References: