Esophageal Neoplasms
Conditions
Keywords
neoadjuvant chemoradiation, pathologic response, low molecular weight heparin
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.
Interventions
DRUGEnoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable
Patients are going to receive subcutaneouse Enoxaparin (40 mg daily).
RADIATIONRadiotherapy
Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.
Patients are going to receive weekly chemotherapy (paclitaxel \[50 mg/m2\] plus carboplatin \[area under the carve=2\]).
Sponsors
Mashhad University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical response | 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) |
| pathologic response | up to 6 weeks | according to pathologic findings of esophageus specimen (complete Vs incomplete) |
| R staging (residual of tumor) | up to 6 weeks | according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| heparin induced thrombocytopenia | through study completion, an average of 5 weeks | according to complete blood count |
Countries
Iran
Contacts
Primary ContactArezoo Gholami, M.D.
Outcome results
None listed