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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cancer Center, Japan

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.

Eligibility criteria

Qualifiers

Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.

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.

Clinical N0M0 with cervical to abdominal contrast-enhanced CT.

The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM1.

Disqualifiers

Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curable with local therapy.

Active infection requiring systemic therapy.

Fever over 38 degrees Celsius

Female during pregnancy, within 28 days of post parturition, or during lactation. Male who wants a partner's pregnancy.

Trial design

Treatments tested in this trial

  • Chemoradiotherapy

Treatment groups

280 Participants
are divided into 2 treatment groups

Sponsors and collaborators