A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC

Recruiting Phase 3 Interventional Study
Esophageal Squamous Cell Carcinoma
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.
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At a Glance
Age
20 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
280 (estimated)
Sponsor
National Cancer Center, Japan · Government
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About This Trial

This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.

Trial Locations
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Eligibility Criteria
Inclusion criteria: 1. Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma. 2. All lesions located in the thoracic esophagus. Secondary lesions with an absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus…
Contacts

Motoo Nomura, MD/PhD

81335422511

mnomura@kuhp.kyoto-u.ac.jp

CONTACT