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.
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.
Check if I qualifyExtracted 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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