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.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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• Written informed consent.
• Histologically confirmed squamous cell carcinoma of the esophagus.
• 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 cardiac function. Left ventricular ejection fraction \> 50%.
• Age from 18 years to 70
Locations
Other Locations
Russian Federation
N.N. Blokhin National Medical Research Center of Oncology
RECRUITING
Moscow
Contact Information
Primary
Omar Abouhaidar, MD, PhD
abouhaidar@yandex.ru
+79269125902
Backup
Parvin Akhmedov
Akhmedovparvin@gmail.com
+79267333323
Time Frame
Start Date:2022-09-14
Estimated Completion Date:2027-09-14
Participants
Target number of participants:156
Treatments
Active_comparator: Neoadjuvant Chemoradiotherapy
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.
Experimental: Neoadjuvant Chemotherapy
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.