Trials / Recruiting
RecruitingNCT05547529
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.
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- Sponsor
- Blokhin's Russian Cancer Research Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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).
Detailed description
It is a prospective open-label randomized phase III clinical trial sponsored by N.N. Blokhin NMRC of Oncology. 156 patients with locally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0M0, cT1-4aN1-3M0) are recruited and randomly assigned into the neoadjuvant chemoradiotherapy group (nCRT) followed by esophagectomy and the neoadjuvant chemotherapy group (nCT) followed by esophagectomy according to the proportion of 1:1. The safety, efficacy of protocols and prognosis of patients are compared between the two regimens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy. | Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy. |
| PROCEDURE | Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy | Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy |
Timeline
- Start date
- 2022-09-14
- Primary completion
- 2025-09-14
- Completion
- 2027-09-14
- First posted
- 2022-09-21
- Last updated
- 2022-10-04
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT05547529. Inclusion in this directory is not an endorsement.