Clinical trial · Interventional
The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
An Open-Label Randomized Clinical Trial to Evaluate the Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer cT3-4aN0M0, cT1-4aN1-3M0.
NCT05547529CI-TRIAL-00061231recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the safety, feasibility and outcomes of neoadjuvant chemotherapy followed by esophagectomy versus neoadjuvant chemoradiotherapy followed by esophagectomy for locally advanced resectable esophageal squamous cell carcinoma cT3-4aN0M0, cT1-4aN1-3M0. This is non-inferiority study (neoadjuvant chemoradiotherapy has no advantage over neoadjuvant chemotherapy).
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy. | Procedure | — | UNRESOLVED |
| Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant Chemoradiotherapy
- description
- Carboplatin (AUC 2 mg/mL per min) and Paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. A total radiation dose of 41,4 Gy was given in 23 fractions of 1,8 Gy, 5 days per week. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.
- interventionNames
- Procedure: Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
- type
- EXPERIMENTAL
- label
- Neoadjuvant Chemotherapy
- description
- 4 cycles of DCF regimen (docetaxel 75 mg/m2 day, CDDP 75 mg/m2 and 5FU at 750 mg/m2/ day for 5 days) every 3 weeks. Patients with dysphagia 3 оr with weight loss more then 10% 6 cycles of modified-DCF regimen will be performed (mDCF, docetaxel 50 mg/m2 day, CDDP 50 mg/m2 day and 5-FU at 2400 mg/m2/day for 2 days) every 3 weeks. After neoadjuvant therapy, patients receive Ivor-Lewis or Mckeown Esophagectomy.
- interventionNames
- Procedure: Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. * Histologically confirmed squamous cell carcinoma of the esophagus. * Clinical stage cT1-4aN1-3M0 (AJCC/UICC 8th Edition). * Indications for surgical esophageal resection * ECOG status 0-1. * Adequate bone marrow function (White Blood Cells \> 3.0 x 109/L; Neutrophil \> 2.0 × 109/L; Hemoglobin \> 90 g/L; Platelets \> 100 x 109/L). * Adequate liver function (Total bilirubin \< 1.5 x Upper Level of Normal (ULN); Aspartate transaminase (AST) and Alanine transaminase (ALT) \< 3.0 x ULN); * Adequate renal function (Glomerular filtration rate (CCr) \> 50 ml/min. * Adequate cardiac function. Left ventricular ejection fraction \> 50%. * Age from 18 years to 70 Exclusion Criteria: * Clinical stage cT4bcN0cM0 (AJCC/UICC 8th Edition). * Patients with advanced non-operable or metastatic esophageal cancer. * Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy. * Patients with another previous or current malignant disease. * Allergy or contraindications to Paclitaxel, Carboplatin, Docetaxel, Cisplatin or Fluoruracil. * Patients with active infection of immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); HIV seropositivity; HBV DNA or HCV RNA positive. * Severe concomitant diseases (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors, etc.). * Clinically significant coronary artery disease (NYHA III / IV), congestive heart failure (NYHAIII / IV), clinically significant cardiomyopathy, myocardial infarction within the last 6 months, or high risk of uncontrolled arrhythmia. * Chronic inflammatory diseases of the gastrointestinal tract * Acute infectious diseases. * Pregnancy or breast feeding. * Serious concomitant physical and mental illness / abnormalities or territorial reasons that may prevent the patient from participating in the protocol and adherence to the protocol schedule. * Foreigners or persons with limited legal rights. * Any medical, geographic, or social circumstance, that in the opinion of the investigator excludes the patient's participation in the protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.