RecruitingPhase 3NCT04328948

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

A Randomized Controlled Phase III Trial of Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer


Sponsor

National Cancer Center, Japan

Enrollment

280 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether adding preventive radiation to nearby lymph nodes improves outcomes for people with a specific early-stage esophageal cancer (squamous cell type, stage cT1bN0M0 — meaning the cancer is in the shallow layer of the esophageal wall and has not spread to lymph nodes or distant organs). The treatment being tested is radiation combined with chemotherapy. **You may be eligible if...** - You are 20 years or older - You have been diagnosed with squamous cell carcinoma of the thoracic esophagus confirmed by biopsy - Scans show the cancer has not spread to lymph nodes or other organs - The tumor is staged as penetrating the inner layer of the esophageal wall (cT1b) - You are in good physical condition (ECOG 0–1) - Your blood, liver, kidney, and breathing tests meet required levels - You have not had prior radiation to the chest or neck area **You may NOT be eligible if...** - You have had another cancer in the past 5 years - You prefer surgery as your initial treatment - You have had prior esophageal radiation or chemotherapy - Your tumor is in the cervical (neck) esophagus Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONChemoradiotherapy

Chemoradiotherapy


Locations(1)

National Cancer Center Hospital

Tokyo, Japan

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NCT04328948


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