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| ID | Type | Description | Link |
|---|---|---|---|
| IRCT2016070628814N1 | Registry Identifier | the Iranian Registry of Clinical Trials |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable | Drug | Patients are going to receive subcutaneouse Enoxaparin (40 mg daily). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| heparin induced thrombocytopenia | according to complete blood count | through study completion, an average of 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arezoo Gholami, M.D. | Contact | 00989155252690 | gholamia931@mums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mashhad University of Medical Sciences | Recruiting | Mashhad | Razavi Khorasan Province | 917751365 | Iran |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 28, 2018 | |
| Reset | Oct 30, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 28, 2018 | Oct 30, 2018 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000711671 | enoxaparin sodium |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiotherapy | Radiation | Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions. |
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| Chemotherapeutic Combinations | Drug | Patients are going to receive weekly chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]). |
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| 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |