The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
Recruiting
Phase 3
Interventional Study
Esophageal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 156 (estimated)
- Sponsor
- Blokhin's Russian Cancer Research Center · Other
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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).
Trial Locations
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Eligibility Criteria
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 …
Contacts