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OncoMatch/Clinical Trials/NCT04328948

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

Is NCT04328948 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for esophageal squamous cell carcinoma.

Phase 3RecruitingNational Cancer Center, JapanNCT04328948Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage CT1B

Clinical N0M0 with cervical to abdominal contrast-enhanced CT. The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: endoscopic resection — pT1a-LPM (pM2) / pT1a-MM (M3) disease or pT1a-MM (M3) disease without vascular infiltration

complete resection by EMR/ESD with either pT1a-LPM (pM2) / pT1a-MM (M3) disease or pT1a-MM (M3) disease without vascular infiltration

Cannot have received: radiotherapy

No history of radiotherapy for the neck, chest, and upper abdomen for any cancers.

Cannot have received: chemotherapy

Exception: allowed if disease-free interval >= 3 years

No chemotherapy or hormone therapy with less than 3 years of disease-free interval for any cancers.

Cannot have received: hormone therapy

Exception: allowed if disease-free interval >= 3 years

No chemotherapy or hormone therapy with less than 3 years of disease-free interval for any cancers.

Lab requirements

Blood counts

WBC<=12,000/mm3; ANC>=1,500/mm3; Hb>=10.0 g/dL; PLT>=10,000/mm3

Kidney function

Ccr>=60 mL/min

Liver function

T-bil<=1.5 mg/dL; AST<=100 IU/L; ALT<=100 IU/L

Major organ function is preserved. 1) WBC<=12,000/mm3 2) ANC>=1,500/mm3 3) Hb>=10.0 g/dL 4) PLT>=10,000/mm3 5) T-bil<=1.5 mg/dL 6) AST<=100 IU/L 7) ALT<=100 IU/L 8) SpO2>=95% 9) Ccr>=60 mL/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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