The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBlokhin's Russian Cancer Research Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
  • Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy

Treatment groups

156 Participants
are divided into 2 treatment groups