Clinical trial · Interventional
Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer
The Effect of Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer on the Clinical and Pathologic Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapeutic Combinations | Drug | — | UNRESOLVED |
| Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- enoxaparin
- description
- 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).
- interventionNames
- Drug: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable
- Radiation: Radiotherapy
- Drug: Chemotherapeutic Combinations
- type
- ACTIVE_COMPARATOR
- label
- control
- description
- 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.
- interventionNames
- Radiation: Radiotherapy
- Drug: Chemotherapeutic Combinations
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available